Predicate Devices

Reference Devices

K122231, K123988, K182448, K203808, K210826, K211812, K220562, K103280, K133377, K231967

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes various dental implant abutments and related components. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making process. The focus is on the physical properties, materials, and mechanical performance of the devices.

Therapeutic

Yes

The device is intended to restore chewing function and provide prosthetic support for dental restorations, which are therapeutic functions.

Diagnostic

No

Explanation: The device description and intended use clearly state that the product is a dental implant abutment system for prosthetic support and restoring chewing function. There is no mention of diagnostic capabilities, such as identifying conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description lists multiple physical components (Scan Healing Abutment, Temporary Abutment, etc.) made of specific materials with surface treatments and dimensions, indicating they are hardware devices. The performance studies also focus on physical properties and biocompatibility of these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is surgically placed in the body to provide support for dental restorations and restore chewing function. This is a therapeutic and structural function, not a diagnostic one.
Device Description: The description lists various components of a dental implant system, all of which are physical devices intended for implantation or attachment to an implant. None of them are described as reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.

Therefore, the MegaGen Dental Implant Abutment and its associated components are considered medical devices, but not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patients chewing function.

All digitally designed abutments for use with ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture.

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

Scan Healing Abutment

The Scan Healing Abutment is intended for use as accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tisue for acceptance of a final abutment and restoration. It is used for non-submerged type surgery or for two-stage surgery. It is made of Ti-6AI-4V-EL, and offered in machined and anodizing surface. It is supplied using gamma irradiation during manufacturing process. It is single use devices.

Temporary Abutment

The Temporary Abutment is used in conjunction with fixture to provisional restoration and connected to the Fixture with Abutment Screw. It has knurled surface on the top part, which allows for better retention of resin or wax. It is not customizable but used as it is. The Temporary Abutment is supplied non-sterilized by the user according to the IFU and intended for single use.

Temporary Cylinder

The Temporary Cylinder is used in conjunction with Muti-unit Abutment or AXA Abutment to provide support for provisional restoration and used for fabricating the single and multi-unit prosthesis. It is connected to the Abutment with Cylinder Screw. It has knurled surface on the top part (Post Cylinder), which allows for better retention of resin or wax. This component is not customizable but used as it is.

Comfort Cap

Comfort Cap is used for protecting a Solid Abutment after taking iminimizing irritation to tongue and oral mucosa. It easily makes a temporary crown by resin build up.

Healing Cap

The Healing Cap is intended to be used during intra-oral soft tissue healing to protect the Multi-unit Angled Abutments or AXA Abutment (Straight, Angled) and prepare the soft tissue for the prosthetic procedure (temporary and final restoration). It is a two-piece type, connected to the abutment with Cylinder Screw. The Healing Cap is a temporary component used for soft tissue healing.

Healing Cap Screw

Healing Cap Screw is used for connecting AXA Abutment (Straight) or AXA Abutment (Angled) to Healing Cap. It is made of Ti-6AI-4V-ELI and offered in machined surface. The Healing Cap Body Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

Milling Abutment

The Milling Abutment is used in conjunction with fixture to provide support for cement and screw retained type final prosthesis and used for establishing an adequate safety margin from occlusal line by hand milling of the post part. It is connected to the Fixture with Abutment Screw. The Milling Abutment can be modified in post height only (The minimum post height is 4mm above the abutment collar/gingival height). The Milling abutment is supplied non-sterilized by the user according to the IFU and intended for single use.

EZ Post Abutment/Extra EZ Post Abutment

The EZ Post Abutment is used in conjunction with fixture to provide support for cement and screw retained type final prosthesis. It is connected to the Fixture with Abutment Screw. It is made of Ti-6AI-4V-ELI, and offered in machined, anddizing blue, gold, brown and green. The EZ Post abutment is supplied non-sterilized by the user according to the IFU and intended for single use.

EZ Post Cylinder

The EZ Post Cylinder is used in conjunction with Multi-unit Abutment or Multi-unit Angled Abutment to provide support for provisional restoration and used for fabricating the single and multi-unit prosthesis. It is connected to the Abutment with Cylinder Screw.

ZrGEN Abutment

The titanium base is not milled but will be used as it is. The titanium base will be cemented Zirconia top-haff with FDA-cleared Dental cement (Kuraray Noritake Dental - PANAVIATM SA Cement Universal Automix, K183537). The ZrGEN Abutment is intended to be sent to a MegaGen-validated milling center for manufacturing Zirconia top-half and for cementing with Zirconia top-half (IVOCLAR VIVADENT, INC. - IPS E.MAX CAD/IPS E.MAX ZIRCAD, K051705).
The ZrGEN Abutment is a two-piece abutment composed of the stock titanium base cemented together with the zirconia tophalf to complete the final finished device. This abutment is to be used only with implants placed straight.

Multi-unit Abutment

The Multi-unit Abutment is a straight type, the lower part is intended to the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis.
The Multi-unit Abutment is a one-piece type and not contained an anti-rotational feature, allowing the abutment to be screwed directly in to the endosseous dental implant by their lower thread part. The thread part has three types of male screws depending on the fixture system to be connected. The Multi-unit is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

Multi-unit Angled Abutment

The Multi-unit Angled Abutment is an angled type, the lower part is intended to be placed on the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis.
The Multi-unit Angled Abutment is a two-piece type, contained an anti-rotational feature, and connected to the endosseous dental implant by Multi-unit Abutment Screw. The Multi-unit is an angled type and available in 17° and 30°. The Multi-unit Angled Abutment is compatible with the prosthet in this submission. The Multi-unit Angled Abutment is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

AXA Abutment (Straight)

The straight type of AXA Abutment, the lower part is intended to be placed on the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis.

AXA Abutment (Angled)

The angled type of AXA Abutment, the lower part is intended to be placed on the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis. The angled type of AXA Abutment is a two-piece type, contained an anti-rotational feature, and connected to the endosseous dental implant by Abutment Screw. There are two connection types: the internal hex/octa type and the non-hex/non-octa type.

Abutment Screw

The Abutment Screw is used for connecting abutment for each Implant System. The lower part has male screws depending on the fixture system to be connected. It is made of Ti-6AI-4V-ELI and offered in machined surface. The Abutment Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

Cylinder Screw

Cylinder Screw is used for connecting Multi-unit Abutment or Multi-unit Angled Abutment to Healing Cap, Temporary cylinder or EZ Post Cylinder. It is made of Ti-6AI-4V-ELI and offered in machined surface. The Cylinder Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

Crown Screw

The Crown Screw is a prosthetic component connected to abutment and in prosthetic rehabilitation. It is made of Ti-6AI-4V-ELI and offered in machined surface. The crown Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary or mandibular areas

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing

Biocompatibility

The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. All of the subject device materials and manufacturing have been previously cleared in K182448 and K231967. Therefore, no additional biocompatibility testing was performed in this submission.

Sterilization validation

The Scan Healing Abutment is provided as sterile device is cleaned and sterilized by gamma irradiation. The final sterilization process, v-ray irradiation is commissioned to an outside in it. The Sterility Assurance Level (SAL) shall comply with EN556, that is the Highest Assurance Level (Class 3), 10-6. ysterilization doze shall be set based on this and for y-sterilization doze and irradiation shall be determined in accordance with ISO11137-Method I.
The subject devices excluding the sterile device are supplied in non-sterile state. Sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 17665-1, 2 to verify the sterility assurance level (10").

Performance (Physical Properties) Test

The bench tests have been performed in accordance with 'ISO 14801' and the recommendations of 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to evaluate the performance of the subject devices and the test results met the pre-set criteria.

MR Compatibility

Non-clinical worst-case MRI review was performed to evaluate the metallic MegaGen Dental Implant system as MR Conditional in the MRI environment using scientific rationale and published literature (Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.

Clinical Testing

No clinical studies are submitted.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110955

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K122231, K123988, K182448, K203808, K210826, K211812, K220562, K103280, K133377, K231967

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

January 22, 2024

MegaGen Implant Co., Ltd. Seo MinGi 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun Daegu, 42921 REPUBLIC OF KOREA

Re: K233450

Trade/Device Name: MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment

Regulatory Class: Class II Product Code: NHA Dated: October 20, 2023 Received: October 20, 2023

Dear Seo MinGi:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K233450

Device Name

MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Cylinder; Comfort Cap; Healing Cap: Healing Cap Screw; Milling Abutment; EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw

Indications for Use (Describe)

MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patients chewing function.

All digitally designed abutments for use with ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture.

Type of Use (Select one or both, as applicable)
Research Use Only (For all OFF-MYCis Plasmids) Gene Therapy Use (For OFF-MYCis Plasmids Only)	Research Use Only (For all OFF-MYCis Plasmids)	Gene Therapy Use (For OFF-MYCis Plasmids Only)
Research Use Only (For all OFF-MYCis Plasmids)	Gene Therapy Use (For OFF-MYCis Plasmids Only)

|× | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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General Summary of Submission

510(k) Summary for K233450

Date: January 22, 2024

1. Applicant / Submitter

MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828

2. Submission Correspondent

MinGi Seo MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: +82-53-222-3892 Fax: +82-53-247-2254 Email: ra14@imegagen.com

3. Device

| | • Trade Name: | MegaGen Dental Implant Abutment - Scan Healing Abutment;
Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap;
Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post
Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment;
Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment
(Angled); Abutment Screw; Cylinder Screw; Crown Screw |
|--|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Common Name: | Endosseous Dental Implant Abutment |
| | • Classification Name: | Endosseous dental implant abutment |
| | • Classification Product Code: | NHA |
| | • Classification regulation: | Class II, 21 CFR 872.3630 |

4. Predicate Device

• Primary Predicate Device:

K110955 AnyRidge Internal Implant System

. Reference Devices:

K122231 XPEED AnyRidge Internal Implant System K123988 AnyOne Internal Implant System K182448 BLUEDIAMOND Implant System K203808 Multi-unit Abutment System K210826 Healing Abutment, Cover Screw K211812 BLUDEDIAMOND IMPLANT, Abutment Screw K220562 TiGEN, ZrGEN, Scan Healing Abutment

5

K103280 BHdental Implant System K133377 NobelProcera Angulated Screw Channel Abutment Replace K231967 ARi ExCon Implant System

5. Description

. Scan Healing Abutment

The Scan Healing Abutment is intended for use as accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tisue for acceptance of a final abutment and restoration. It is used for non-submerged type surgery or for two-stage surgery. It is made of Ti-6AI-4V-EL, and offered in machined and anodizing surface. It is supplied using gamma irradiation during manufacturing process. It is single use devices.

Device	Component
Scan Healing
Abutment	XPEED AnyRidge Internal Implant System
$ \varnothing $ 4.7, 5.7 x 6.9, 7.9, 9.9, 11.9mm

The Scan Healing Abutment is compatible with following MegaGen Implants cleared under:

| Manufacturer | Compatible Implant
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|-----------------|-----------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | XPEED AnyRidge
Internal Implant
System | XPEED AnyRidge
Internal Fixture | K110955
K122231
K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,
7.4, 7.9, 8.4 |

Temporary Abutment

The Temporary Abutment is used in conjunction with fixture to provisional restoration and connected to the Fixture with Abutment Screw. It has knurled surface on the top part, which allows for better retention of resin or wax. It is not customizable but used as it is. The Temporary Abutment is supplied non-sterilized by the user according to the IFU and intended for single use.

The dimensions of Temporary Abutment are follows:

Device	Component
Temporary
Abutment	XPEED AnyRidge Internal Implant System
$Ø$ 4.2, 4.7, 5.7, 6.7 x 6.9, 7.9, 9.9, 11.9 mm
	BLUEDIAMOND IMPLANT System
$Ø$ 4.2, 4.7, 5.7, 6.7 x 12.35, 13.85 mm

The Temporary Abutment is compatible with following MegaGen Implants cleared under:

| Manufacturer | Compatible Implant
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|-----------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | XPEED AnyRidge
Internal Implant
System | XPEED AnyRidge
Internal Fixture | K110955
K122231
K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,
7.4, 7.9, 8.4 |
| | BLUEDIAMOND
IMPLANT System | BLUEDIAMOND
IMPLANT | K182448
K211812 | Internal
Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,
5.5 |

Note] There is the modification of the Implant System Name for FDA cleared AnyRidge Octa 1 Implant System to BLUEDIAMOND IMPLANT System with K182448. According to below FDA Guidance*, MEGAGEN manages it as a 510(k) VARIANCE REQIEST FORM for changes.

*Deciding When to Submit a 510(k) for a Change to an Existing Device / Guidance for Industry and Food and Drug Administration Staff / Document issued on October 25, 2017.

· Temporary Cylinder

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The Temporary Cylinder is used in conjunction with Muti-unit Abutment or AXA Abutment to provide support for provisional restoration and used for fabricating the single and multi-unit prosthesis. It is connected to the Abutment with Cylinder Screw. It has knurled surface on the top part (Post Cylinder), which allows for better retention of resin or wax. This component is not customizable but used as it is.

The dimensions of Temporary Cylinder are follows:

Device	Component
Temporary
Cylinder	Common
$\phi$ 4.8, 4.9, 5.7 x 12mm

Comfort Cap .

Comfort Cap is used for protecting a Solid Abutment after taking iminimizing irritation to tongue and oral mucosa. It easily makes a temporary crown by resin build up.

The dimensions of Comfort Cap are follows:

Device	Component
Comfort Cap	Common
$\varnothing$ 5.0 x 5.4mm

. Healing Cap

The Healing Cap is intended to be used during intra-oral soft tissue healing to protect the Multi-unit Angled Abutments or AXA Abutment (Straight, Angled) and prepare the soft tissue for the prosthetic procedure (temporary and final restoration). It is a two-piece type, connected to the abutment with Cylinder Screw. The Healing Cap is a temporary component used for soft tissue healing.

The dimensions of Healing Cap are follows:

Device	Component
Healing Cap	Common
	$\varnothing$ 6.8 x 4.2, 5.5 mm
	$\varnothing$ 4.9 x 5.5 mm
	$\varnothing$ 5.0, 5.5, 6.0, 6.1, 6.5 x 6.0, 8.0 mm

. Healing Cap Screw

Healing Cap Screw is used for connecting AXA Abutment (Straight) or AXA Abutment (Angled) to Healing Cap. It is made of Ti-6AI-4V-ELI and offered in machined surface. The Healing Cap Body Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

The dimensions of Healing Cap are follows:

Device	Component
Healing Cap
Screw	Common
$\varnothing$ 2.5 x 3.3 mm

- Milling Abutment

The Milling Abutment is used in conjunction with fixture to provide support for cement and screw retained type final prosthesis and used for establishing an adequate safety margin from occlusal line by hand milling of the post part. It is connected to the Fixture with Abutment Screw. The Milling Abutment can be modified in post height only (The minimum post height is 4mm above the abutment collar/gingival height). The Milling abutment is supplied non-sterilized by the user according to the IFU and intended for single use.

The dimensions of Milling Abutment are follows:

Device	Component
Milling
Abutment	XPEED AnyRidge Internal Implant System
$\varnothing$ 4.0 x 22.4mm

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| Manufacturer | Compatible Implant
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|-----------------|-----------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | XPEED AnyRidge
Internal Implant
System | XPEED AnyRidge
Internal Fixture | K110955
K122231
K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,
7.4, 7.9, 8.4 |

The Milling Abutment is compatible with following MegaGen Implants cleared under:

. EZ Post Abutment/Extra EZ Post Abutment

The EZ Post Abutment is used in conjunction with fixture to provide support for cement and screw retained type final prosthesis. It is connected to the Fixture with Abutment Screw. It is made of Ti-6AI-4V-ELI, and offered in machined, anddizing blue, gold, brown and green. The EZ Post abutment is supplied non-sterilized by the user according to the IFU and intended for single use.

The dimensions of EZ Post Abutment are follows:

Device	Component
	XPEED AnyRidge Internal Implant System
Ø 5.0 x 12.9mm
Post Height: 5.5mm
EZ Post
Abutment
/Extra EZ Post
Abutment	BLUEDIAMOND IMPLANT System
Ø 4.0, 5.0 x 7.85, 8.85, 9.35, 9.85, 10.35, 10.85, 11.35, 11.85,12.35, 12.85, 13.35, 13.85, 14.85mm
Ø 6.0, 7.0 x 9.35, 10.35, 10.85, 11.35, 11.85,12.35, 12.85, 13.35, 13.85, 14.35, 14.85, 15.35, 16.35mm
Post Height: 4.0, 7.0 mm

The EZ Post Abutment is compatible with following MegaGen Implants cleared under:

| Manufacturer | Compatible Implant
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|---------------------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | XPEED AnyRidge
Internal Implant
System | XPEED AnyRidge
Internal Fixture | K110955
K122231
K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,
7.4, 7.9, 8.4 |
| MegaGen
Implant Co.,
Ltd. | BLUEDIAMOND
IMPLANT System | BLUEDIAMOND
IMPLANT | K182448
K211812 | Internal
Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,
5.5, 5.6, 6.0, 6.5, 7.0 |

[Note] There is the modification of the Implant System Name for FDA cleared AnyRidge Octa 1 Implant System to BLUEDIAMOND IMPLANT System with K182448. According to below FDA Guidance*, MEGAGEN manages it as a 510(k) VARIANCE REQIEST FORM for changes.

*Deciding When to Submit a 510(k) for a Change to an Existing Device / Guidance for Industry and Food and Drug Administration Staff / Document issued on October 25, 2017.

EZ Post Cylinder .

The EZ Post Cylinder is used in conjunction with Multi-unit Abutment or Multi-unit Angled Abutment to provide support for provisional restoration and used for fabricating the single and multi-unit prosthesis. It is connected to the Abutment with Cylinder Screw.

The dimensions of EZ Post Cylinder are follows:

Device	Component
	Common
EZ Post Cylinder	Ø 4.8, 4.9, 5.7 x 4.2, 5.5, 5.8, 7.0, 9.0 mm
Post Height (Total Length) : 4.2, 5.5, 5.8 7.0, 9.0 mm

· ZrGEN Abutment

The titanium base is not milled but will be used as it is. The titanium base will be cemented Zirconia top-haff with FDA-cleared Dental cement (Kuraray Noritake Dental - PANAVIATM SA Cement Universal Automix, K183537). The ZrGEN Abutment is intended to be sent to a MegaGen-validated milling center for manufacturing Zirconia top-half and for cementing with Zirconia top-half (IVOCLAR VIVADENT, INC. - IPS E.MAX CAD/IPS E.MAX ZIRCAD, K051705).

8

The ZrGEN Abutment is a two-piece abutment composed of the stock titanium base cemented together with the zirconia tophalf to complete the final finished device. This abutment is to be used only with implants placed straight.

			The dimensions of ZrGEN Abutment are follows:
--	--	--	-----------------------------------------------	--

Device	Component
ZrGEN
Abutment	XPEED AnyRidge Internal Implant System
Ø 4.5, 5.0, 5.5, 6.0 x 7.5, 8.6, 9.0, 10.1, 11.0, 11.4, 12.4, 13.4, 14.4 mm
	BLUEDIAMOND IMPLANT System
Ø 4.4, 4.5 x 6.45, 7.35, 7.95, 8.85, 9.85, 9.95, 10.35, 10.85, 11.35, 13.35 mm
	Common
Ø 4.8 x 5.5, 6.5, 8.5 mm

The allowable ranges of design parameters after CAD/CAM patient-matching are follows:

Zirconia top-half	Minimum wall thickness (mm)	0.5
	Maximum angulation (°)	0
	Minimum gingival collar (ø)	8
	Maximum gingival collar (ø)	10
	Minimum Gingival collar height (mm)	2
	Maximum Gingival collar height (mm)	5
	Minimum post height above the abutment collar/gingival height(mm)	7
	Maximum post height above the abutment collar/gingival height(mm)	15

The ZrGEN Abutment is compatible with following MegaGen Implants cleared under:

| Manufacturer | Compatible Implant
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|---------------------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | XPEED AnyRidge
Internal Implant
System | XPEED AnyRidge
Internal Fixture | K110955
K122231
K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,
7.4, 7.9, 8.4 |
| MegaGen
Implant Co.,
Ltd. | BLUEDIAMOND
IMPLANT System | BLUEDIAMOND
IMPLANT | K182448
K211812 | Internal
Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,
5.5, 5.6, 6.0, 6.5, 7.0 |

[Note] There is the modification of the Implant System Name for FDA cleared AnyRidge Octa 1 Implant System to BLUEDIAMOND IMPLANT System with K182448. According to below FDA Guidance*, MEGAGEN manages it as a 510(k) VARIANCE REQIEST FORM for changes.

*Deciding When to Submit a 510(k) for a Change to an Existing Device / Guidance for Industry and Food and Drug Administration Staff / Document issued on October 25, 2017.

Multi-unit Abutment

The Multi-unit Abutment is a straight type, the lower part is intended to the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis.

The Multi-unit Abutment is a one-piece type and not contained an anti-rotational feature, allowing the abutment to be screwed directly in to the endosseous dental implant by their lower thread part. The thread part has three types of male screws depending on the fixture system to be connected. The Multi-unit is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

Device	Component
Multi-unit Abutment	XPEED AnyRidge Internal Implant System
$\varnothing$ 4.8 x 12.75, 13.75 mm
BLUEDIAMOND IMPLANT System
$\varnothing$ 4.8 x 14.8, 13.8 mm
AnyOne Internal Implant System
$\varnothing$ 4.8 x 13.84, 14.84 mm

The dimensions of Multi-unit Abutment are follows:

The Multi-unit Abutment is compatible with following MegaGen Implants cleared under:

9

| Manufacturer | Compatible Implant
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|--------------------|------------------|-----------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | XPEED AnyRidge
Internal Implant
System | XPEED AnyRidge
Internal Fixture | K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,
7.4, 7.9, 8.4 |
| | AnyOne Internal
Implant System | AnyOne Internal
Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,
7.3, 7.8, 8.3 |
| | BLUEDIAMOND
IMPLANT System | BLUEDIAMOND
IMPLANT | K182448 | Internal
Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,
5.5 |

(Note) There is the modification of the Implant System Name for FDA cleared AnyRidge Octa 1 Implant System to BLUEDIAMOND IMPLANT System with K182448. According to below FDA Guidance*, MEGAGEN manages it as a 510(k) VARIANCE REQIEST FORM for changes.

*Deciding When to Submit a 510(k) for a Change to an Existing Device / Guidance for Industry and Food and Drug Administration Staff / Document issued on October 25, 2017.

Multi-unit Angled Abutment

The Multi-unit Angled Abutment is an angled type, the lower part is intended to be placed on the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis.

The Multi-unit Angled Abutment is a two-piece type, contained an anti-rotational feature, and connected to the endosseous dental implant by Multi-unit Abutment Screw. The Multi-unit is an angled type and available in 17° and 30°. The Multi-unit Angled Abutment is compatible with the prosthet in this submission. The Multi-unit Angled Abutment is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

The dimensions of Multi-unit Abutment are follows:

Device	Component
Multi-unit
Angled
Abutment	XPEED AnyRidge Internal Implant System
Ø 4.8 x 7.4, 7.9, 8.4, 8.9 mm
BLUEDIAMOND IMPLANT System
Ø 4.8 x 8.35, 9.35, 9.85, 10.85 mm
AnyOne Internal Implant System
Ø 4.8 x 7.94, 8.94 mm

The Multi-unit Abutment, Multi-unit Angled Abutment is compatible with following MegaGen Implants cleared under:

| Manufacturer | Compatible Implant
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|--------------------|------------------|-----------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | XPEED AnyRidge
Internal Implant
System | XPEED AnyRidge
Internal Fixture | K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,
7.4, 7.9, 8.4 |
| | AnyOne Internal
Implant System | AnyOne Internal
Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,
7.3, 7.8, 8.3 |
| | BLUEDIAMOND
IMPLANT System | BLUEDIAMOND
IMPLANT | K182448 | Internal
Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,
5.5 |

[Note] There is the modification of the Implant System Name for FDA cleared AnyRidge Octa 1 Implant System to BLUEDIAMOND IMPLANT System with K182448. According to below FDA Guidance*, MEGAGEN manages it as a 510(k) VARIANCE REQIEST FORM for changes.

*Deciding When to Submit a 510(k) for a Change to an Existing Device / Guidance for Industry and Food and Drug Administration Staff / Document issued on October 25, 2017.

· AXA Abutment (Straight)

The straight type of AXA Abutment, the lower part is intended to be placed on the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis.

10

The dimensions of AXA Abutment (Straight) are follows:

Device	Component
AXA Abutment
(Straight)	XPEED AnyRidge Internal Implant System
Ø 4.0, 5.0 x 11.05, 12.05, 13.05, 15.05, 17.05, 19.05 mm
BLUEDIAMOND IMPLANT System
Ø 4.0, 5.0 x 12.10, 13.10, 14.10, 16.10, 18.10, 20.10 mm
AnyOne Internal Implant System
Ø 4.0, 5.0 x 12.143, 13.143, 14.143, 16.143, 18.143, 20.143 mm

The AXA Abutment (Straight) is compatible with following MegaGen Implants cleared under:

| Manufacturer | Compatible Implant
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|---------------------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | XPEED AnyRidge
Internal Implant
System | XPEED AnyRidge
Internal Fixture | K110955
K122231
K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,
7.4, 7.9, 8.4 |
| | AnyOne Internal
Implant System | AnyOne Internal
Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,
7.3, 7.8, 8.3 |
| | BLUEDIAMOND
IMPLANT System | BLUEDIAMOND
IMPLANT | K182448
K211812 | Internal
Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,
5.5, 5.6, 6.0, 6.5, 7.0 |

▪ AXA Abutment (Angled)

The angled type of AXA Abutment, the lower part is intended to be placed on the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis. The angled type of AXA Abutment is a two-piece type, contained an anti-rotational feature, and connected to the endosseous dental implant by Abutment Screw. There are two connection types: the internal hex/octa type and the non-hex/non-octa type.

The dimensions of AXA Abutment (Angled) are follows:

Device	Component
AXA Abutment
(Angled)	XPEED AnyRidge Internal Implant System
Ø 4.0, 5.0 x 6.4, 8.4, 10.4 mm
	BLUEDIAMOND IMPLANT System
Ø 4.0, 5.0 x 6.85, 8.85, 10.85 mm
	AnyOne Internal Implant System
Ø 4.0, 5.0 x 6.64, 8.64, 10.64 mm

The AXA Abutment (Angled) is compatible with following MegaGen Implants cleared under:

| Manufacturer | Compatible Implant
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|------------------------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | XPEED AnyRidge
Internal Implant
System | XPEED AnyRidge
Internal Fixture | K110955
K122231
K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,
7.4, 7.9, 8.4 |
| | AnyOne Internal
Implant System | AnyOne Internal
Fixure | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,
7.3, 7.8, 8.3 |
| | BLUEDIAMOND
IMPLANT System | BLUEDIAMOND
IMPLANT | K182448
K211812 | Internal
Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,
5.5.
5.6, 6.0, 6.5, 7.0 |

· Abutment Screw

The Abutment Screw is used for connecting abutment for each Implant System. The lower part has male screws depending on the fixture system to be connected. It is made of Ti-6AI-4V-ELI and offered in machined surface. The Abutment Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

11

The dimensions of Abutment Screw are follows:

Device	Component
Abutment Screw	XPEED AnyRidge Internal Implant System
Ø 2.0 x 8.5, 9.45, 11.45 mm
BLUEDIAMOND IMPLANT System
Ø 2.2 x 9.9, 7.9 mm
AnyOne Internal Implant System
Ø 2.1 x 9.6, 10.6, 12.6 mm

The Abutment Screw is compatible with following MegaGen Implants cleared under:

| Manufacturer | Compatible Implant
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|---------------------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | XPEED AnyRidge
Internal Implant
System | XPEED AnyRidge
Internal Fixture | K110955
K122231
K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,
7.4, 7.9, 8.4 |
| | AnyOne Internal
Implant System | AnyOne Internal
Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,
7.3, 7.8, 8.3 |
| | BLUEDIAMOND
IMPLANT System | BLUEDIAMOND
IMPLANT | K182448
K211812 | Internal
Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,
5.5, 5.6, 6.0, 6.5, 7.0 |

. Cylinder Screw

Cylinder Screw is used for connecting Multi-unit Abutment or Multi-unit Angled Abutment to Healing Cap, Temporary cylinder or EZ Post Cylinder. It is made of Ti-6AI-4V-ELI and offered in machined surface. The Cylinder Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

The dimensions of Cylinder Screw are follows:

Device	Component
Cylinder Screw	Common
$\varnothing$ 2.1 x 4.9 mm

- Crown Screw

The Crown Screw is a prosthetic component connected to abutment and in prosthetic rehabilitation. It is made of Ti-6AI-4V-ELI and offered in machined surface. The crown Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.

The dimensions of Crown Screw are follows:

Device	Component
Crown Screw	Ø 2.3, 2.4 x 5.2, 7.0mm
Ø 2.1 x 4.65 mm

6. Indications for use

The MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patients chewing function. All digitally designed abutments for use with ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture.

7. Basis for Substantial Equivalence

The MegaGen Dental Implant Abutment is substantially equivalent to the predicate device in terms of indication for use, technical characteristic and function. They are material and have similar design. The size range of the subject of the subject device slightly differ from the predicate device however it is very minor not

12

affecting substantial equivalence.

Based on the comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device.

(1) Scan Healing Abutment

	Subject Device	Predicate device	Reference Device
510(k) No.	-	K110955	K220562
Device Name	Scan Healing Abutment	Healing Abutment	Scan Healing Abutment
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant Abutment
is intended to be surgically placed in the
maxillary or mandibular areas for the
purpose providing prosthetic support for
dental restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use
with ZrGEN Abutment are intended to be
sent to a MegaGen validated milling
center for manufacture.	The AnyRidge Internal Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas for
the purpose providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function.
Smaller implants (less than Ø6.0 mm) are
dedicated for immediate loading when
good primary stability is achieved and
with appropriate occlusal loading. Larger
implants are dedicated for the molar
region and are indicated for delayed
loading.	Scan Healing Abutment is intended for
use on endosseous dental implants in
the edentulous or partially edentulous
maxilla or mandible, as an aid in
prosthetic rehabilitation.
Design	Image: Scan Healing Abutment	Image: Healing Abutment	Image: Scan Healing Abutment
Diameter (Ø)	4.7, 5.7 mm	4.2, 5.2, 6.2, 7.2, 10.0 mm	4.2, 4.7, 5.7, 6.7 mm
Gingival Height	2.4, 3.4, 5.4, 7.4 mm	3.5, 4.5, 5.5, 6.5, 7.5 mm	2.4, 3.4, 5.4, 7.4 mm
Total Length	6.9 ~ 11.9 mm	8.4 ~ 14.4 mm	6.9 ~ 11.85mm
Connection
Interface	Internal Conical Connection	Internal Conical Connection	Internal Conical Connection
Material	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6A1-4V ELI(ASTM F136-13)
Surface
Treatment	Anodizing	Machined	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization
Shelf-life	5 years	5 years	5 years
Principle of
Operation	The Scan Healing Abutment is fastened
into the female screw of dental implant
and support the gingival shaping. And it
is a scannable that can help with the
impression intraoral without removal.	The Healing Abutment is fastened into
the female screw of dental implant and
support the gingival shaping.	The Scan Healing Abutment is fastened
into the female screw of dental implant
and support the gingival shaping. And it
is a scannable that can help with the
impression intraoral without removal.
Compatible
Implant
System	XPEED AnyRidge Internal Implant System	XPEED AnyRidge Internal Implant System	XPEED AnyRidge Internal Implant System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System
Substantial Equivalence Discussion

1. Similarities

The subject device has the same characteristic for the followings compared to the predicate device.

Indications for Use, Design, Diameter, Gingival Height, Connection Interface, Material, Surface Treatment, Single Use, Sterilization, Shelf Life, Principle of Operation

2. Difference

The subject device has the different characteristics for the followings compared to the predicate device.

Total Length

The total length of the subject device (11.9 mm) is longer than the reference device and other lengths are within range of the reference device. Since this size difference is very minor it does not cause a matter in substantial equivalence. And the total length includes the connection length of each implant system and therefore does not affect substantial equivalence.

13

3. Discussion

The Subject device and predicate device have common in Indications for sue, Design, Diameter, Gingival Height, Connection Interface, Material, Surface Treatment, Single Use, Sterilization, Shelf Life and Principle of Operation. And the difference is only the total Length. But these do not affect device's substantial equivalence. Also, the subject device is intended for temporary use.

Based on the information in the submission, it is concluded that the subject device is substantially equivale device.

14

(2) Temporary Abutment

	Subject Device	Predicate Device	Reference Device1	Reference Device2
510(k) No.	-	K110955	K182448	K203808
Device Name	Temporary Abutment	Temporary Abutment	Temporary Abutment	Multi-unit Abutment
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant
Abutment is intended to be
surgically placed in the maxillary
or mandibular areas for the
purpose providing prosthetic
support for dental restorations
(Crown, bridges, and
overdentures) in partially or
fully edentulous individuals. It is
used to restore a patients
chewing function. All digitally
designed abutments for use
with ZrGEN Abutment are
intended to be sent to a
MegaGen validated milling
center for manufacture.	The AnyRidge Internal Implant
System is intended to be
surgically placed in the
maxillary or mandibular molar
areas for the purpose providing
prosthetic support for dental
restorations (Crown, bridges,
and overdentures) in partially
or fully edentulous individuals.
It is used to restore a patients
chewing function. Smaller
implants (less than 6.0 mm) are
dedicated for immediate
loading when good primary
stability is achieved and with
appropriate occlusal loading.
Larger implants are dedicated
for the molar region and are
indicated for delayed loading.	The AnyRidge Octa 1
Implant System is intended
to be surgically placed in
the maxillary or mandibular
molar areas for the purpose
providing prosthetic
support for dental
restorations (Crown,
bridges, and overdentures)
in partially or fully
edentulous individuals. It is
used to restore a patient's
chewing function in the
following situation and with
the clinical protocols:

Immediate loading when
good primary stability is
achieved and with
appropriate occlusal
loading. | The Multi-unit Abutment,
Multi-unit Angled Abutment
is intended to be surgically
placed in the maxillary or
mandibular arches for the
purpose providing prosthetic
support for dental
restorations (Crown, bridges,
and overdentures) in
partially or fully edentulous
individuals. |
| Design | | | | |
| Diameter (Ø) | 3.5,4.0, 4.5, 4.75 mm | 4.0, 5.0 mm | 4.0, 4.5, 5.0 mm | 4.8 mm |
| Gingival
Height | 1.8, 2.0, 2.2,2.8, 3.0, 3.2,
3.8, 4.0, 4.2,4.8, 5.0, 5.2 mm | 2.0 mm | 2.0, 3.0 mm | 0.6, 1.5, 2.0, 2.5, 3.0,
3.5, 4.0, 4.5, 5.0, 5.5 mm |
| Post Height | 7.5, 10.0 mm | 10 mm | 10.0 mm | 1.8, 2.2 mm |
| Total Length | 14.4 ~ 19.35 mm | 14.4 mm | 14.85 ~ 17.35mm | 6.2 ~ 12.84mm |
| Angulation | Straight | Straight | Straight | Straight |
| Connection
Interface | Hex, Non-Hex
Octa, Non-Octa | Hex, Non-Hex | Octa, Non-Octa | Hex, Non-Hex |
| Material | Ti-6A1-4V ELI(ASTM F136-13) | Ti-6A1-4V ELI(ASTM F136-13) | Ti-6A1-4V ELI(ASTM F136-13) | Ti-6A1-4V ELI(ASTM F136-13) |
| Surface
Treatment | Machined, Anodizing | Machined | Machined, Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle of
Operation | The Temporary Abutment is a
superstructure which is
connected to the Fixtures or
Regular Abutment using the
Abutment Screw.
It is used to provide support for
provisional restoration. | The Temporary Cylinder is a
superstructure which is
connected to the Abutment
using the Screw.
It is used to provide support for
provisional restoration. | The Temporary Abutment is
a superstructure which is
connected to the Fixtures
using the Screw.
It is used to provide support
for provisional restoration. | This product is a pre-
manufactured prosthetic
component directly or
indirectly connected to the
endosseous dental implant
using its threaded part or
screw for aid in prosthetic
rehabilitation. |
| Compatible
Implant
System | XPEED AnyRidge Internal
Implant System
BLUEDIAMOND IMPLANT
System | XPEED AnyRidge Internal
Implant System | BLUEDIAMOND IMPLANT
System | XPEED AnyRidge Internal Implant
System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System |
| Substantial Equivalence Discussion | | | | |

1. Similarities

The subject device has the same characteristic for the followings compared to the predicate and reference devices.

Indications for Use, Design, Angulation Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation

Differences

The subject device has the different characteristic for the followings compared to the predicate device and reference device. - Diameter

Some of diameter (3.5mm) of subject device is smaller than the predicate device while other diameters are within the range of the predicate and reference devices. The difference in size is uery small, so the issue of substantive equivalence does not arise. And the variety of sizes allows for more precise treatment tailored to each patient's condition.

Gingival Height

15

Some of the gingival heights of subject device are different from the predicate device. However, the overall dimensions are within the range of Megagen's licensed reference device. Although there is a difference in the period of use, there is no problem substantive equivalence regarding dimensions. And the variety of sizes allows for more precise treatment tailored to each patient's condition.

- Post Height

Some post heights (7.5mm) of the subject device are smaller than the predicate device while other diameters are within the range of the predicate and reference devices. The difference in size is small, so the issue of substantive equivalence does not arise. And the variety of sizes allows for more precise treatment tailored to each patient's condition.

Total Length
The Total Length of the subject device is longer than the reference device. But the longer total length of the subject device does not cause a matter in substantial equivalence since is intended for temporary use. And the total length includes the connection length of each implant system and therefore does not affect substantial equivalence.

3. Discussion

The subject device and predicate device have common in Indication for use, Design, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the subject device is intended for temporary use.

Based on the information based in submission, we conclude that the substantially equivalent to the predicate device and reference device.

16

(3) Temporary Cylinder
	Subject Device	Predicate device	Reference Device1	Reference Device2
510(k) No.	-	K110955	K203808	K123988
Device Name	Temporary Cylinder	Temporary Cylinder	Temporary Cylinder	Temporary Cylinder
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant
Abutment is intended to be
surgically placed in the
maxillary or mandibular areas
for the purpose providing
prosthetic support for dental
restorations (Crown, bridges,
and overdentures) in partially
or fully edentulous
individuals. It is used to
restore a patients chewing
function. All digitally designed
abutments for use with
ZrGEN Abutment are
intended to be sent to a
MegaGen validated milling
center for manufacture.	The AnyRidge Internal
Implant System is intended to
be surgically placed in the
maxillary or mandibular
molar areas for the purpose
providing prosthetic support
for dental restorations
(Crown, bridges, and
overdentures) in partially or
fully edentulous individuals. It
is used to restore a patient's
chewing function. Smaller
implants (less than Ø6.0 mm)
are dedicated for immediate
loading when good primary
stability is achieved and with
appropriate occlusal loading.
Larger implants are dedicated
for the molar region and are
indicated for delayed loading.	The Multi-unit Abutment,
Multi-unit Angled Abutment is
intended to be surgically
placed in the maxillary or
mandibular arches for the
purpose providing prosthetic
support for dental
restorations (Crown, bridges,
and overdentures) in partially
or fully edentulous individuals.	The AnyOne Internal Implant
System is intended to be
surgically placed in the
maxillary or mandibular
molar areas for the purpose
providing prosthetic support
for dental restorations
(Crown, bridges, and
overdentures) in partially or
fully edentulous individuals.
It is used to restore a
patient's chewing function.
Smaller implants (less than
6.0 mm) are dedicated for
immediate loading when
good primary stability is
achieved and with
appropriate occlusal loading..
Larger implants are
dedicated for the molar
region and are indicated for
delayed loading.
Design	Image: Design	Image: Design	Image: Design	Image: Design
Diameter (Ø)	$4.8, 4.9, 5.7 mm$	$3.8, 4.8, 5.8 mm$	$4.8 mm$	$3.87, 4.8, 5.8 mm$
Gingival Height	$3.0 mm$	$3.0 mm$	$3.0 mm$	$2.8, 3.0 mm$
Post Height	$8.5 mm$	$7.0 mm$	$8.5 mm$	$7.0, 7,5 mm$
Total Length	$12.0 mm$	$10.0 mm$	$12.0 mm$	$10.0, 12.35 mm$
Angulation	Straight	Straight	Straight	Straight
Connection
Interface	Internal Non-Hex	Internal Non-Hex	Internal Octa,
Internal Non-Octa	Internal Octa, Non-Octa
Internal Hex, Non-Hex
Material	Ti-6Al-4V ELI
(ASTM F136-13)	Ti-6Al-4V ELI
(ASTM F136-13)	Ti-6Al-4V ELI
(ASTM F136-13)	CP Ti Grade 4
(ASTM F67-13)
Surface
Treatment	Machined	Machined	Machined	Machined
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle of
Operation	Temporary Cylinder is used in
conjunction with Multi-unit
Abutment to provide support
for provisional restoration.	Temporary Cylinder is used in
conjunction with Multi-unit
Abutment to provide support
for provisional restoration.	Temporary Cylinder is used in
conjunction with Multi-unit
(Angled) Abutment (N type) to
provide support for
provisional restoration.	Temporary Cylinder is used
in conjunction with Octa
Abutment and Multi-unit
(Angled) Abutment (S type)
to provide support for
provisional restoration.
Compatible
Implant
System	XPEED AnyRidge Internal
Implant System
BLUDIAMOND Implant
System	XPEED AnyRidge Internal
Implant System	XPEED AnyRidge Internal
Implant System
AnyOne Internal Implant
System
BLUDIAMOND Implant System	AnyOne Internal Implant
System
Substantial Equivalence Discussion

Similarities

The subject device has the same characteristic for the followings compared to the predicate devices.

Indication for use, Design, Gingival Height, Post Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization, Principle of Operation
Diameter 2. Differences

17

The subject device has the different characteristic for the followings compared to the predicate device.

Diameter

Some diameters (4.9, 5.7 mm) of the subject device are different from the predicate and reference devices, but thin the range of the predicate device, and other diameters (4.8 mm) are the predicate device. The difference in size is very small, so the issue of substantive equivalence does not arise. And the variety of sizes allows for more precise treatment tailored to each patient's condition.

3. Discussion

The subject device and reference devices have common in all the items except the Diameter differences are explained not affecting on the substantial equivalence.

Based on the information based in submission, we conclude that the substantially equivalent to the reference devices.

18

(4) Comfort Cap
	Subject Device	Predicate device	Reference Device
510(k) No.		K110955	K123988
Device Name	Comfort Cap	Comfort Cap	Comfort Cap
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant Abutment
is intended to be surgically placed in the
maxillary or mandibular areas for the
purpose providing prosthetic support for
dental restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use
with ZrGEN Abutment are intended to be
sent to a MegaGen validated milling
center for manufacture.	The AnyRidge Internal Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas for
the purpose providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function.
Smaller implants (less than Ø6.0 mm) are
dedicated for immediate loading when
good primary stability is achieved and
with appropriate occlusal loading. Larger
implants are dedicated for the molar
region and are indicated for delayed
loading.	The AnyOne™ Internal Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas for
the purpose providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function.
Smaller implants (less than Ø6.0 mm) are
dedicated for immediate loading when
good primary stability is achieved and
with appropriate occlusal loading. Larger
implants are dedicated for the molar
region and are indicated for delayed
loading.
Design	Image: Design of subject device	Image: Design of predicate device	Image: Design of reference device
Diameter (Ø)	5.5 mm	4.0, 5.0, 6.0, 7.0 mm	4.0, 4.5, 5.5, 6.5 mm
Total Length	5.4 mm	5.4 ~ 8.4 mm	5.4 ~ 8.6 mm
Material	POM	POM	POM
Single Use	Yes	Yes	Yes
Sterilization	Non-Sterile	Non-Sterile	Non-Sterile
Principle of
Operation	The Comfort Cap is used for protecting a
Solid Abutment after taking impression,
and minimizing irritation to tongue and
oral mucosa. It easily makes a temporary
crown by resin build up.	The Comfort Cap is used for protecting a
Solid Abutment after taking impression,
and minimizing irritation to tongue and
oral mucosa. It easily makes a temporary
crown by resin build up.	The Comfort Cap is used for protecting a
Solid Abutment after taking impression,
and minimizing irritation to tongue and
oral mucosa. It easily makes a temporary
crown by resin build up.
Compatible
Implant
System	XPEED AnyRidge Internal Implant System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System	XPEED AnyRidge Internal Implant System	AnyOne Internal Implant System
Substantial Equivalence Discussion
1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device and reference device

Indications for Use, Design, Diameter, Total length, Material, Single Use, Sterilization, Principle Operation

2. Differences

There are no differences with the predicate device and reference device.

3. Discussion

The subject device and reference device have common in Indications for Use, Design, Diameter, Total length, Material, Single Use, Sterilization, and Principle Operation.

19

	Subject Device	Predicate device	Reference Device
510(k) No.		K110955	K203808
Device Name	Healing Cap	Healing Cap	Comfort Cap	Healing Cap
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co.,
Ltd.	MegaGen Implant Co.,
Ltd.	MegaGen Implant Co., Ltd.
Indications
for Use
Statement	The MegaGen Dental Implant
Abutment is intended to be
surgically placed in the
maxillary or mandibular areas
for the purpose providing
prosthetic support for dental
restorations (Crown, bridges,
and overdentures) in partially
or fully edentulous individuals.
It is used to restore a patients
chewing function. All digitally
designed abutments for use
with ZrGEN Abutment are
intended to be sent to a
MegaGen validated milling
center for manufacture.	The AnyRidge Internal Implant System is intended to be
surgically placed in the maxillary or mandibular molar areas
for the purpose providing prosthetic support for dental
restorations (Crown, bridges, and overdentures) in partially
or fully edentulous individuals. It is used to restore a
patient's chewing function. Smaller implants (less than Ø6.0
mm) are dedicated for immediate loading when good
primary stability is achieved and with appropriate occlusal
loading. Larger implants are dedicated for the molar region
and are indicated for delayed loading.		The Multi-unit Abutment,
Multi-unit Angled Abutment
is intended to be surgically
placed in the maxillary or
mandibular arches for the
purpose providing prosthetic
support for dental
restorations (Crown, bridges,
and overdentures) in partially
or fully edentulous
individuals.
Design
Diameter (Ø)	4.9, 5.0, 5.5, 6.0, 6.1, 6.5,
6.8 mm	4.0, 6.0 mm	4.0, 5.0, 6.0, 7.0 mm	4.9, 6.8 mm
Total Length	4.2 ~ 8.0 mm	3.70 ~ 3.75mm	5.4 ~ 8.4 mm	4.2 mm
Connection
Interface	Two-piece Healing Cap
(with titanium alloy screw)	Two-piece Healing Cap
(with titanium alloy
screw)	One-piece	Two-piece Healing Cap
(with titanium alloy
screw)
Material	Ti-6Al-4V ELI
(ASTM F136-13)	Ti-6Al-4V ELI
(ASTM F136-13)	POM	Ti-6Al-4V ELI
(ASTM F136-13)
Surface
Treatment	Machined, Anodizing	Machined	Non-Sterile	Machined
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle of
Operation	The Healing Cap is intended to
be used during intra-oral soft
tissue healing to protect the
Multi-unit Abutments and
Multi-unit Angled Abutments or
AXA Abutment (Straight,
Angled) and prepare the soft
tissue for the prosthetic
procedure (temporary and final
restoration). It is a two-piece
type, connected to the
abutment with Cylinder Screw.
The Healing Cap is a temporary
component used for soft tissue
healing.	Healing Cap is used for
protecting Octa Abutment
and minimizing irritation to
tongue and oral mucosa
during period of gingival
healing.	The Comfort Cap is used for
protecting a Solid Abutment
after taking impression, and
minimizing irritation to
tongue and oral mucosa. It
easily makes a temporary
crown by resin build up.	Healing Cap is used for
protecting Multi-unit
Abutment or Multi-unit
Angled Abutment and
minimizing irritation to
tongue and oral mucosa
during period of gingival
healing.
Compatible
Implant
System	XPEED AnyRidge Internal
Implant System
AnyOne Internal Implant
System
BLUEDIAMOND IMPLANT
System	XPEED AnyRidge Internal
Implant System	XPEED AnyRidge Internal
Implant System	XPEED AnyRidge Internal
Implant System
AnyOne Internal Implant
System
BLUEDIAMOND IMPLANT
System

The subject device has the same characteristic for the followings compared to the predicate device. - Indication for use, Design, Connection Interface, Material, Single Use, Sterilization, Principle of Operation

Differences

The subject device has the different characteristic for the followings compared to the predicate and reference devices.

20

- Diameter

Some of diameters (5.0, 5.5, 6.1, 6.5 mm) of subject device are slightly different with the predicate device and reference device while other diameters are within the range of the predicate device. The difference in size is very small, so the issue of substantive equivalence does not arise. And the variety of sizes allows for more precise treatment tailored to each patient's condition.

- Total Length

The total length of the subject device is different from predicate device but is within the range of the predicate device. So the issue of substantive equivalence does not arise. And the variety of sizes allows for more precise treatment tailored to each patient's condition.

- Surface Treatment

The subject device is treated with machined and anodizing while the predicate device is treated with machined, but anodizing, a surface treatment method, is the same as the MegaGen's cleared reference device in other comparison tables.

3. Discussion

। The subject device and predicate device have common in Indication for use, Design, Connection Interface, Material, Single Use, Sterilization and Principle of Operation. The dimension is slightly different with the predicate device and the reference device, but it does not cause a matter in substantial equivalence since the size difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition. Also, the subject device is intended for temporary use.
Based on the information based in submission, we conclude that the substantially equivalent to the reference devices.

21

(6) Healing Cap Screw

	Subject Device	Reference Device 1	Reference Device 2
510(k) No.	-	K123988	K203808
Device Name	Healing Cap Screw	Flat Cylinder Screw	Cylinder Screw
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications
for Use
Statement	The MegaGen Dental Implant Abutment
is intended to be surgically placed in the
maxillary or mandibular areas for the
purpose providing prosthetic support for
dental restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use
with ZrGEN Abutment are intended to be
sent to a MegaGen validated milling
center for manufacture.	The AnyOne™ Internal Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas for
the purpose providing prosthetic
support for dental restorations (Crown,
bridges, and overdentures) in partially or
fully edentulous individuals. It is used to
restore a patient's chewing function.
Smaller implants (less than Ø6.0 mm) are
dedicated for immediate loading when
good primary stability is achieved and
with appropriate occlusal loading. Larger
implants are dedicated for the molar
region and are indicated for delayed
loading.	The Multi-unit Abutment, Multi-unit
Angled Abutment is intended to be
surgically placed in the maxillary or
mandibular arches for the purpose
providing prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals.
Design	Image: Healing Cap Screw Design	Image: Flat Cylinder Screw Design	Image: Cylinder Screw Design
Diameter (Ø)	2.5 mm	2.1 mm	2.0 mm
Total Length	3.30 mm	5.9 mm	3.4 mm
Material	Ti-6Al-4V ELI (ASTM F136-13)	Ti-6Al-4V ELI (ASTM F136-13)	Ti-6Al-4V ELI (ASTM F136-13)
Surface
Treatment	Machined	Machined	Machined
Single Use	Yes	No	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle of
Operation	Healing Cap Screw is used for connecting
AXA Abutment (Straight) or AXA
Abutment (Angled) to Healing Cap. It is
made of Ti-6AI-4V-ELI and offered in
machined surface. The Healing Cap Body
Screw is supplied non-sterile, to be
sterilized by the user according to the
IFU and intended for single use.	Flat Cylinder Screw is used for
connecting Abutment or Healing cap or
Cylinder.	Cylinder Screw is used for connecting
Multi-unit Abutment or Multi-unit
Angled Abutment to Healing Cap,
Temporary cylinder or CCM Cylinder.
Compatible
Implant
System	XPEED AnyRidge Internal Implant System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System	XPEED AnyRidge Internal Implant System	XPEED AnyRidge Internal Implant System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System
Substantial Equivalence Discussion

1. Similarities

The subject device has the same characteristic for the followings compared to the reference devices.

Indication for use, Design, Material, Surface Treatment, Single Use, Sterilization, Principle of Operation

2. Differences

The subject device has the different characteristic for the followings compared to the predicate and reference devices.

Diameter

The Diameter of subject device is slightly different with the Reference devices. But, the virety of the size can be possible to operate more precise treatment to meet each patient's condition. Therefore, it does not cause a matter in substantial equivalence.

- Total Length

The Total Length of subject device is slightly different with the Reference device2. But, the size can be possible to operate more precise treatment to meet each patient's condition. Therefore, it does not cause a matter in substantial equivalence.

3. Discussion

The subject device and reference devices have common in Indication for use, Design, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The Diameter and Total Length are slightly different with reference devices, but it does not cause a matter in substantial equivalence since the size differences are very minor, and the size can be possible to operate more precise treatment to meet each patient's condition. Also, the is intended for temporary use.

22

Based on the information based in submission, we conclude that the substantially equivalent to the reference devices.

23

(7) Milling Abutment
	Subject Device	Predicate Device	Reference Device
510(k) No.	-	K110955	K182448
Device Name	Milling Abutment	Milling Abutment	Milling Abutment
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant
Abutment is intended to be surgically
placed in the maxillary or mandibular
areas for the purpose providing
prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use
with ZrGEN Abutment are intended to
be sent to a MegaGen validated milling
center for manufacture.	The Xpeed AnyRidge Internal Implant
System is intended to be surgically placed
in the maxillary or mandibular molar
areas for the purpose providing
prosthetic support for dental restorations
(Crown, bridges, and overdentures) in
partially or fully edentulous individuals. It
is used to restore a patients chewing
function. Smaller implants (less than 6.0
mm) are dedicated for immediate loading
when good primary stability is achieved
and with appropriate occlusal loading.
Larger implants are
dedicated for the molar region and are
indicated for delayed loading.	The AnyRidge Octa 1 Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas for
the purpose providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function in
the following situation and with the
clinical protocols:

Immediate loading when good primary
stability is achieved and with appropriate
occlusal loading. |
| Design | Image: Subject Device Design | Image: Predicate Device Design | Image: Reference Device Design |
| Diameter (Ø) | $4.0 mm$ | $4.0, 5.0, 6.0, 7.0mm$ | $6.0, 8.0 mm$ |
| Gingival Height | $0.8 mm$ | $2.8 mm$ | $0.8, 1.8, 2.8, 3.8, 4.8 mm$ |
| Post Height | $19.0 mm$ | $9.2 mm$ | $9.0 mm$ |
| Total Length | $22.4 mm$ | $12.35 mm$ | $18.35 mm$ |
| Angulation | Straight | Straight | Straight |
| Connection | Hex, Non-Hex | Hex, Non-Hex | Octa, Non-Octa |
| Interface | - | - | - |
| Material | Ti-6A1-4V ELI(ASTM F136-13) | Ti-6A1-4V ELI(ASTM F136-13) | Ti-6A1-4V ELI(ASTM F136-13) |
| Surface | Anodizing | Anodizing | Anodizing |
| Treatment | - | - | - |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of
Operation | This product is a superstructure which
is connects with the fixtures using the
Abutment Screw. It replaces the
functions of the missing teeth as a
dental abutment. | This product is a superstructure which is
connects with the fixtures using the
Abutment Screw. It replaces the
functions of the missing teeth as a
dental abutment. | This product is a superstructure which is
connects with the fixtures using the
Abutment Screw. It replaces the
functions of the missing teeth as a
dental abutment. |
| Compatible
Implant System | XPEED AnyRidge Internal Implant
System | XPEED AnyRidge Internal Implant System | BLUEDIAMOND IMPLANT System |
| Substantial Equivalence Discussion | | | |
| | Subject Device | Predicate Device | Reference Device |
| 510(k) No. | - | K110955 | K182448 |
| Device Name | EZ Post Abutment | EZ Post Abutment | EZ Post Abutment |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for
Use Statement | The MegaGen Dental Implant
Abutment is intended to be surgically
placed in the maxillary or mandibular
areas for the purpose providing
prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use
with ZrGEN Abutment are intended to
be sent to a MegaGen validated milling
center for manufacture. | The Xpeed AnyRidge Internal Implant
System is intended to be surgically placed
in the maxillary or mandibular molar
areas for the purpose providing
prosthetic support for dental restorations
(Crown, bridges, and overdentures) in
partially or fully edentulous individuals. It
is used to restore a patients chewing
function. Smaller implants (less than 6.0
mm) are dedicated for immediate loading
when good primary stability is achieved
and with appropriate occlusal loading.
Larger implants are
dedicated for the molar region and are
indicated for delayed loading. | The AnyRidge Octa 1 Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas for
the purpose providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function in
the following situation and with the
clinical protocols:
Immediate loading when good primary
stability is achieved and with appropriate
occlusal loading. |
| Design | | | |
| Diameter (Ø) | 4.0, 5.0, 6.0, 7.0mm | 4.0, 5.0, 6.0, 7.0mm | 4.0, 5.0, 6.0, 7.0mm |
| Gingival Height | 0.8, 1.8, 2.8, 3.8, 4.8, 5.0mm | 1.8, 2.8, 3.8, 4.8mm | 0.8, 1.8, 2.8, 3.8, 4.8 mm |
| Post Height | 4.0, 5.5, 7mm | 5.5, 7mm | 4.0, 5.5, 7mm |
| Total Length | 6.15 ~ 13.15 mm | 7.85 ~ 16.35 mm | 7.85 ~ 14.85 mm |
| Angulation | Straight | Straight | Straight |
| Connection
Interface | Hex, Non-hex
Octa, Non-Octa | Hex, Non-hex | Octa, Non-Octa |
| Material | Ti-6A1-4V ELI(ASTM F136-13) | Ti-6A1-4V ELI(ASTM F136-13) | Ti-6A1-4V ELI(ASTM F136-13) |
| Surface
Treatment | Anodizing | Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of
Operation | This product is a superstructure which
is connects with the fixtures using the
Abutment Screw. It replaces the
functions of the missing teeth as a
dental abutment. | This product is a superstructure which is
connects with the fixtures using the
Abutment Screw. It replaces the
functions of the missing teeth as a dental
abutment. | This product is a superstructure which is
connects with the fixtures using the
Abutment Screw. It replaces the
functions of the missing teeth as a dental
abutment. |
| Compatible
Implant System | XPEED AnyRidge Internal Implant
System
BLUEDIAMOND IMPLANT System | XPEED AnyRidge Internal Implant System | BLUEDIAMOND IMPLANT System |
| | | Substantial Equivalence Discussion | |
| 1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device and reference device.
Indication for use, Design, Diameter, Post height, Angulation, Connection Interface, Material, Surface Treatment, Single Use,
Sterilization and Principle of Operation.

Differences
The subject device has the different characteristic for the followings compared to the predicate device and reference device.

Gingival Height
Some of the Gingival Height (5mm) is longer than the predicate device and reference device while other Gingival Heights are same
with the predicate device and reference device. The difference in size is very small, so the issue of substantive equivalence does
not arise. Also, In order to evaluate the stability and performance due to differences in the submitted devices, we selected
subjected AXA Abutment (Angled type) as the worst case representative device and conducted a fatigue test. Test results
confirmed that there was no essential difference in product performance and stability.
Total Length
The Total Length of the subject device is slightly different with the predicate device and reference device. But, the variety of the
size can be possible to operate more precise treatment to meet each patient's condition. Therefore, it does not cause a matter in
substantial equivalence.

Discussion | | | |
| The subject device and reference device have common in Indication for use, Design, Diameter, Post height, Angulation, Connection
Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. | | | |

1. Similarities

The subject device has the same characteristic for the followings compared to the predicate device.

Indication for use, Design, Diameter, Gingival Height, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation

Differences

The subject device has the different characteristic for the followings compared to the predicate and reference devices. - Post Height, Total Length

The Total length and Post height of the subject device is longer than the predicate device and reference device. But it does not matter in substantial equivalence since the milling abutment is desight of the post part can be modified by hand milling. Also, In order to evaluate the stability and performance due to differences in the submitted devices we selected subjected AXA Abutment (Angled type) as the worst case representative device a fatigue test. Test results confirmed that there was no essential difference in product performance and stability.

Discussion

The subject device and predicate device have common in Indication for use, Design, Diameter, Gingival Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. Also, In order to evaluate the stability and performance in the submitted devices, we selected the worst model

and conducted a fatigue test. Test results confirmed that there was no difference in Substantial equivalence.

Based on the information based in submission, we conclude that the substantially equivalent to the predicate device and reference device.

24

(8) EZ Post Abutment

Also, In order to evaluate the stability and performance due to differences in the submitted devices, we selected the worst model and conducted a fatigue test. Test results confirmed that there was no difference in Substantial equivalence.

Based on the information based in submission, we conclude that the substantially equivalent to the reference device.

25

9) EZ Post Cylinder

(9) EZ Post Cylinder	Subject Device	Reference Device 1	Reference Device 2
510(k) No.		K182448	K203554
Device Name	EZ Post Cylinder	EZ Post Cylinder	EZ Post Cylinder
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant
Abutment is intended to be surgically
placed in the maxillary or mandibular
areas for the purpose providing
prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use
with ZrGEN Abutment are intended to
be sent to a MegaGen validated milling
center for manufacture.	The AnyRidge Octa 1 Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas for
the purpose providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function in the
following situation and with the clinical
protocols:

Immediate loading when good primary
stability is achieved and with appropriate
occlusal loading | The Multi-unit Abutment, Multi-unit
Angled Abutment is intended to be
surgically placed in the maxillary or
mandibular arches for the purpose
providing prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. |
| Design | | | |
| Diameter (Ø) | 4.8, 4.9, 5.7 mm | 4.0, 5.0, 6.0 mm | 5.0 mm |
| Total Length | 4.2 ~ 9.0 mm | 5.5 ~ 7.0 mm | 8.5 mm |
| Angulation | Straight | Straight | Straight |
| Connection
Interface | Internal Non-Hex | Octa, Non-Octa | Hex, Non-Hex |
| Material | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6A1-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Machined, Anodizing | Anodizing | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of
Operation | EZ Post Cylinder is used in conjunction
with Multi-unit Abutment or AXA
Abutment to provide support for
provisional restoration. | EZ Post Cylinder is used in conjunction
with Octa Abutment to provide support
for cement and screw type final
prosthesis. EZ Post Cylinder and Octa
Abutment are connected by combining
the female screw on the top of the Octa
Abutment and Cylinder Screw. | The EZ Post Cylinder is used in
conjunction with Regular Abutment to
provide support for cement and screw
type final prosthesis. It is connected to
the Abutment using Abutment Screw. |
| Compatible
Implant
System | XPEED AnyRidge Internal Implant
System
BLUDIAMOND IMPLANT System
AnyOne Internal Implant System | BLUDIAMOND IMPLANT System | XPEED AnyRidge Internal Implant
System
BLUDIAMOND IMPLANT System
AnyOne Internal Implant System |
| Substantial Equivalence Discussion | | | |

1. Similarities

The subject device has the same characteristic for the followings compared to the reference device.

Indication for use, Design, Angulation Interface, Material, Surface Treatment, Single Use, Sterilization, Principle of Operation

2. Differences

The subject device has the different characteristic for the followings compared to the reference device.

Diameter
All of diameters of the subject device are different with the reference devices but the different diameters are within range of the reference device 1. Also, the difference in size issue of substantive equivalence does not arise. And the variety of sizes allows for more precise treatment tailored to each patient's condition.

- Total Length

The total length of the subject device (9.0mm) is slightly longer than the total length of reference device (8.5mm). For the longest length (9.0 mm), fatigue testing was performed by connecting it with an AXA abutment (Angled type). Test results confirmed that there was no substantial difference in product performance and stability.

3. Discussion

The subject device and reference device have common in Indication for use, Design, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. Also, the proposed product is a straight type abutment so the fatigue test was performed as a representative of the worst case model with angle.

Based on the information based in submission, we conclude that the substantially equivalent to the reference

26

devices.

27

	(10) ZrGEN Abutment
--	---------------------

(10) ZrGEN Abutment
	Subject Device	Predicate device	Reference Device 1	Reference Device 2
510(k) No.		K110955	K123988	K220562
Device Name	ZrGEN Abutment	EZ Post Abutment	ZrGEN Abutment	ZrGEN Abutment
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant
Abutment is intended to be
surgically placed in the
maxillary or mandibular areas
for the purpose providing
prosthetic support for dental
restorations (Crown, bridges,
and overdentures) in partially
or fully edentulous individuals.
It is used to restore a patients
chewing function. All digitally
designed abutments for use
with ZrGEN Abutment are
intended to be sent to a
MegaGen validated milling
center for manufacture.	The Xpeed AnyRidge Internal
Implant System is intended
to be surgically placed in the
maxillary or mandibular
molar areas for the purpose
providing prosthetic support
for dental restorations
(Crown, bridges, and
overdentures) in partially or
fully edentulous individuals.
It is used to restore a
patients chewing function.
Smaller implants (less than
6.0 mm) are dedicated for
immediate loading when
good primary stability is
achieved and with
appropriate occlusal loading.
Larger implants are
dedicated for the molar
region and are indicated for
delayed loading.	The AnyOne™ Internal
Implant System is intended
to be surgically placed in the
maxillary or mandibular
molar areas for the purpose
providing prosthetic support
for dental restorations
(Crown, bridges, and
overdentures) in partially or
fully edentulous individuals.
It is used to restore a
patient's chewing function.
Smaller implants (less than
Ø6.0 mm) are dedicated for
immediate loading when
good primary stability is
achieved and with
appropriate occlusal loading.
Larger implants are
dedicated for the molar
region and are indicated for
delayed loading.	The TiGEN Abutment, ZrGEN
Abutment and Scan Healing
Abutment are intended for
use on endosseous dental
implants in the edentulous
or partially edentulous
maxilla or mandible, as an
aid in prosthetic
rehabilitation.
For TiGEN Abutment and
ZrGEN Abutment, all digitally
designed abutments for use
with TiGEN Abutment and
ZrGEN Abutment are
intended to be sent to a
MegaGen-validated milling
center for manufacture.
Titanium base
component
representative
image	Image: Titanium base component representative image	Image: Titanium base component representative image	Image: Titanium base component representative image	Image: Titanium base component representative image
Diameter (Ø) of
the titanium base
component	4.0, 4.5, 4.8, 5.0, 5.5, 6.0
mm	4.0, 5.0, 6.0, 7.0mm	4.0, 4.4, 5.0, 5.5, 6.5mm	3.9, 4.0, 4.3, 4.5, 5.0, 5.5,
6.0 mm
Gingival Height of
the titanium base
component	0.6, 1.5, 2.3, 3.0, 4.0 mm	1.8, 2.8, 3.8, 4.8 mm	0.6, 1.5, 3.0, 4.0 mm	0.6, 1.5, 3.0, 4.0 mm
Post Height of the
titanium base
component	4.5, 5.5, 6.0, 6.2,6.5, 8.0,
8.5 mm	5.5, 7 mm	4.5, 6.0, 8.0 mm	4.5, 6.0, 8.0 mm
Total Length	4.5~14.4 mm	7.85~ 16.35 mm	5.8~8.9 mm	7.5~10.10 mm
Angulation	Ti base (0°), Zirconia top half (0°)	Straight	Ti base (0°), Zirconia top half (0°)	Ti base (0°), Zirconia top half (0°)
Connection
Interface	Internal Conical Connection	Internal Conical
Connection	Internal Conical
Connection	Internal Conical
Connection
Material	Ti-6A1-4V ELI(ASTM F136-13)
*Zirconia (K051705)	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6A1-4V ELI(ASTM F136-13)
*Zirconia (K051705)	Ti-6A1-4V ELI(ASTM F136-13)
*Zirconia (K051705)
Surface
Treatment	Machined	Anodizing	Machined	Machined
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-Sterile	Non-Sterile	Non-Sterile	Gamma sterilization
Principle of
Operation	The ZrGEN Abutment is used to
provide support for customized
prosthetic restorations such as
copings and crowns using FDA-
clear Zirconia block. The ZrGEN
Abutment itself is not to be
machined but used as it is. The
Zirconia top-half of ZrGEN
Abutments are intended to be
sent to a MegaGen-validated
milling center for manufacture	This product is a
superstructure which is
connects with the fixtures
using the Abutment Screw. It
replaces the functions of the
missing teeth as a dental
abutment.	The ZrGEN Abutment is used
to provide support for
customized prosthetic
restorations such as copings
and crowns using FDA-clear
Zirconia block. The ZrGEN
Abutment itself is not to be
machined but used as it is.
The Zirconia top-half of
ZrGEN Abutments are
intended to be sent to a
MegaGen-validated milling	The ZrGEN Abutment is used
to provide support for
customized prosthetic
restorations such as copings
and crowns using FDA-clear
Zirconia block. The ZrGEN
Abutment itself is not to be
machined but used as it is.
The Zirconia top-half of
ZrGEN Abutments are
intended to be sent to a
MegaGen-validated milling
	allowable range of design
parameters provided by
MegaGen.		center for manufacture and
must be designed with the
allowable range of design
parameters provided by
MegaGen.	center for manufacture and
must be designed with the
allowable range of design
parameters provided by
MegaGen.
Compatible
Implant System	XPEED AnyRidge Internal
Implant System
AnyOne Internal Implant
System
BLUEDIAMOND IMPLANT
System	XPEED AnyRidge Internal
Implant System	AnyOne Internal Implant
System	XPEED AnyRidge Internal
Implant System
AnyOne Internal Implant
System
BLUEDIAMOND IMPLANT
System
Substantial Equivalence Discussion
1. Similarities
The subject device has the same characteristic for the followings compared to the reference devices.
- Indication for use, Design, Diameter, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of
Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
- Gingival Height
Some Gingival Heights (0.6, 1.5, 3.0, 4.0 mm) of the subject device are same with the reference devices and other gingival height
(2.3 mm) of the subject device is different from the predicate device and reference devices. But the gingival height of the subject
device is within range of the reference devices.
- Post Height
Some Post Heights (4.5, 5.5, 6.0, 6.2, 8.0 mm) of the subject device are same with the predicate device, reference devices and other
post heights (6.5, 8.5 mm) of the subject device are different from the predicate device and reference devices. But the post height
(6.5 mm) is within range of the reference devices. The post height (8.5 mm) of the subject device is slightly longer than the post
height of reference device. It does not cause a matter in substantial equivalence since this size difference is very minor, and the
variety of the size can be possible to operate more precise treatment to meet each patient's condition.
- Total Length
The total length (4.5 mm) of the subject device is smaller than the reference devices and the total length (14.4 mm) of the subject
device is longer then the reference devices. But the smaller total length (4.5mm) is not a worst case of performance testing and the
total length includes the connection length of each implant system and therefore does not affect substantial equivalence.
Also, In order to evaluate the stability and performance due to differences in the submitted devices, we selected subjected AXA
Abutment (Angled type) as the worst case representative device and conducted a fatigue test. Test results confirmed that there was
no essential difference in product performance and stability.
3. Discussion
The subject device and reference devices have common in Indication for use, Design, Diameter, Connection Interface, Material,
Surface Treatment, Single Use, Sterilization and Principle of Operation.
Also, the proposed product is a straight type abutment so the fatigue test was performed as a representative of the worst case
model with angle.

28

Based on the information in the submission, it is concluded that the substantially equivalent to the predicate device.

29

(11) Multi-unit Abutment

(11) Multi-unit Abutment
	Subject Device	Reference Device
510(k) No.		K182448	K203808
Device Name	Multi-unit Abutment	Multi-unit Abutment	Multi-unit Abutment
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant Abutment
is intended to be surgically placed in the
maxillary or mandibular areas for the
purpose providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use
with ZrGEN Abutment are intended to
be sent to a MegaGen validated milling
center for manufacture.	The AnyRidge Octa 1 Implant System is
intended to be surgically placed in the
maxillary or mandibular arches for the
purpose of providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function in
the following situations and with the
clinical protocols:
-Delayed loading.
-Immediate loading when good primary
stability is achieved and with appropriate
occlusal loading. Larger implants are
dedicated for the molar region.	The Multi-unit Abutment, Multi-unit
Angled Abutment is intended to be
surgically placed in the maxillary or
mandibular arches for the purpose
providing prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals.
Design
Diameter (Ø)	4.8 mm	4.8 mm	4.8 mm
Gingival Height	5.24, 5.3, 6.24, 6.3 mm	1.3, 2.3, 3.3, 4.3 mm	0.6, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5,
5.0, 5.5 mm
Post Height	2.2 mm	2.2 mm	1.8, 2.2 mm
Total Length	12.75 ~ 13.75 mm	9.8 ~ 12.8 mm	6.2 ~ 12.84 mm
Angulation	Straight	Straight	Straight
Connection
Interface	Internal Hex,
Internal Non-Hex,
Internal Conical Connection	Internal Conical
Connection	Internal Hex,
Internal Non-Hex,
Internal Conical Connection
Material	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)
Surface
Treatment	Anodizing	Anodizing, Machined	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Restoration
Type	Single & Multi	Single & Multi	Single & Multi
Principle of
Operation	This product is a pre-manufactured
prosthetic component directly or
indirectly connected to the endosseous
dental implant using its threaded part
or screw for aid in prosthetic
rehabilitation.	This product is a pre-manufactured
prosthetic component directly or
indirectly connected to the endosseous
dental implant using its threaded part or
screw for aid in prosthetic rehabilitation.	This product is a pre-manufactured
prosthetic component directly or
indirectly connected to the endosseous
dental implant using its threaded part or
screw for aid in prosthetic rehabilitation.
Compatible
Implant System	XPEED AnyRidge Internal Implant
System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System	BLUEDIAMOND IMPLANT System	XPEED AnyRidge Internal Implant System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System
Substantial Equivalence Discussion

1. Similarities

The subject device has the same characteristic for the followings compared to the reference devices.

Indication for use, Design, Diameter, Post Height, Angulation, Connection Interface, Material, Single Use, Sterilization, Restoration type, Principle of Operation

2. Differences

The subject device has the different characteristic for the followings compared to the reference devices.

Gingival Height, Total Length

All of the differences (Gingival Height and Total Length) are longer than the reference devices. But the total length includes the connection length of each implant system and therefore does not affect substantial equivalence. The size can be possible to operate more precise treatment to meet each patient's condition. In order to evaluate the stability and performance due to differences in the submitted devices, we selected subjected AXA Abutment (Angled type) as the worst case representative device and conducted a fatigue test. Test results confirmed that there was no essential difference in product performance and

30

stability.

3. Discussion

The subject device and reference devices have common in Indication for use, Design, Diameter, Post Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization type and Principle of Operation. Also, In order to evaluate the stability and performance due to differences in the submitted devices, we selected the worst model with angle and conducted a fatigue test. Test results confirmed that there was no difference in Substantial equivalence.

Based on the information in the submission, it is concluded that the subject device is substantially equivale device.

31

(12) Multi-unit Angled Abutment

	Subject Device	Reference Device
510(k) No.		K182448	K203808
Device Name	Multi-unit Angled Abutment	Multi-unit Angled Abutment	Multi-unit Angled Abutment
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant Abutment
is intended to be surgically placed in the
maxillary or mandibular areas for the
purpose providing prosthetic support for
dental restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use
with ZrGEN Abutment are intended to be
sent to a MegaGen validated milling
center for manufacture.	The AnyRidge Octa 1 Implant System is
intended to be surgically placed in the
maxillary or mandibular arches for the
purpose of providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function in
the following situations and with the
clinical protocols:
-Delayed loading.
-Immediate loading when good primary
stability is achieved and with appropriate
occlusal loading. Larger implants are
dedicated for the molar region.	The Multi-unit Abutment, Multi-unit
Angled Abutment is intended to be
surgically placed in the maxillary or
mandibular arches for the purpose
providing prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals.
Design	Image: Design	Image: Design	Image: Design
Diameter (Ø)	4.8 mm	4.8 mm	4.8, 5.0 mm
Gingival Height	5.24, 5.3, 6.24, 6.3 mm	2.3, 3.3, 4.3 mm	1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5
mm
Post Height	2.2 mm	2.2 mm	2.2, 3.9 mm
Total Length	7.4,~ 10.85 mm	5.35 ~ 8.85mm	3.4~8.85 mm
Angulation	17°, 30°	17°, 30°	17°, 29°, 30°
Connection
Interface	Internal Hex,
Internal Non-Hex, Internal Octa,
Internal Non-Octa	Internal Octa,
Internal Non-Octa	Internal Hex,
Internal Non-Hex, Internal Octa,
Internal Non-Octa
Material	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI (ASTM F136-13)
Surface
Treatment	Anodizing	Machined	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Restoration
Type	Single & Multi	Single & Multi	Single & Multi
Principle of
Operation	This product is a pre-manufactured
prosthetic component connected to the
endosseous dental implant using the
screw and is intended for use as an aid in
prosthetic rehabilitation.	This product is a pre-manufactured
prosthetic component directly or
indirectly connected to the endosseous
dental implant using its threaded part or
screw for aid in prosthetic rehabilitation.	This product is a pre-manufactured
prosthetic component connected to the
endosseous dental implant using the
screw and is intended for use as an aid in
prosthetic rehabilitation.
Compatible
Implant
System	XPEED AnyRidge Internal Implant System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System	BLUEDIAMOND IMPLANT System	XPEED AnyRidge Internal Implant System
AnyOne internal Implant System
BLUEDIAMOND IMPLANT System
	Substantial Equivalence Discussion

1. Similarities

The subject device has the same characteristic for the followings compared to the reference devices.

Indication for use, Design, Diameter, Post Height, Angulation, Connection Interface, Material, Single Use, Sterilization, Restoration type, Principle of Operation

2. Differences

The subject device has the different characteristic for the followings compared to the reference devices.

Gingival Height, Total Length

All of the differences (Gingival Height and Total Length) are longer than the reference devices. But the total length includes the connection length of each implant system and therefore does not affect substantial equivalence. The size can be possible to operate more precise treatment to meet each patient's condition. In order to evaluate the stability and performance due to differences in the submitted devices, we selected subjected AXA Abutment (Angled type) as the worst case representative device and conducted a fatigue test. Test results confirmed that there was no essential difference in product performance and stability.

3. Discussion

The subject Multi-unit Angled abutment and the reference device have common in Indication for use, Design, Diameter, Post Height,

32

Angulation, Connection Interface, Material, Single Use, Sterilization, Restoration type and Principle of Operation. The differences are explained not affecting on the substantial equivalence.

Also, the fatigue test was performed on the subjected AXA Abutment (Angled) as the representative model for the worst asse with an angle to confirm the substantial equivalence. The test result supports that the subject device is substantially equivalent to the predicate, reference device and the difference it not affecting the substantial equivalence.

Based on the information in the submission, it is concluded that the substantially equivalent to the predicate device.

33

(13) AXA Abutment (Straight)

	Subject Device	Reference Device
510(k) No.		K182448	K203808
Device Name	AXA Abutment (Straight)	Multi-unit Abutment	Multi-unit Abutment
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant Abutment
is intended to be surgically placed in the
maxillary or mandibular areas for the
purpose providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use
with ZrGEN Abutment are intended to
be sent to a MegaGen validated milling
center for manufacture.	The AnyRidge Octa 1 Implant System is
intended to be surgically placed in the
maxillary or mandibular arches for the
purpose of providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function in
the following situations and with the
clinical protocols:
-Delayed loading.
-Immediate loading when good
primary stability is achieved and with
appropriate occlusal loading. Larger
implants are dedicated for the molar
region.	The Multi-unit Abutment, Multi-unit
Angled Abutment is intended to be
surgically placed in the maxillary or
mandibular arches for the purpose
providing prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals.
Design
Diameter (Ø)	4.0, 5.0 mm	4.8 mm	4.8 mm
Gingival Height	1.8, 2.8, 3.8, 5.8, 7.8 mm	1.3, 2.3, 3.3, 4.3 mm	0.6, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5,
5.0, 5.5 mm
Post Height	4.0, 6.0 mm	2.2 mm	1.8, 2.2 mm
Total Length	11.05 ~ 20.1 mm	9.8 ~ 12.8 mm	6.2 ~ 12.84 mm
Angulation	Straight	Straight	Straight
Connection
Interface	Internal Hex,
Internal Non-Hex,
Internal Conical Connection	Internal Conical
Connection	Internal Hex,
Internal Non-Hex,
Internal Conical Connection
Material	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)
Surface
Treatment	Anodizing, Machined	Anodizing, Machined	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Restoration
Type	Single & Multi	Single & Multi	Single & Multi
Principle of
Operation	This product is a pre-manufactured
prosthetic component directly or
indirectly connected to the
endosseous dental implant using its
threaded part or screw for aid in
prosthetic rehabilitation.	This product is a pre-manufactured
prosthetic component directly or
indirectly connected to the
endosseous dental implant using its
threaded part or screw for aid in
prosthetic rehabilitation.	This product is a pre-manufactured
prosthetic component directly or
indirectly connected to the
endosseous dental implant using its
threaded part or screw for aid in
prosthetic rehabilitation.
Compatible
Implant System	XPEED AnyRidge Internal Implant
System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System	BLUEDIAMOND IMPLANT System	XPEED AnyRidge Internal Implant System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System
Substantial Equivalence Discussion

1. Similarities

The subject device has the same characteristic for the followings compared to the reference devices.

Indication for use, Design, Angulation Interface, Material, Surface Treatment, Single Use, Sterilization, Restoration type, Principle of Operation

2. Differences

The subject device has the different characteristic for the followings compared to the reference devices.

Diameter
The diameter (4.0 mm) of the subject device is smaller than the reference devices and other diameter (5.0 mm) is bigger than the reference devices. But, the variety of the size can be possible to operate more precise treatment to meet each patient's condition. Therefore, it does not cause a matter in substantial equivalence.

34

- Gingival Height, Post Height, Total Length

All of the differences (Gingival, Post Height, and Total Length) are longer than the reference devices. But the total length includes the connection length of each implant system and therefore does not affect substantial equivalence. The variety of the size can be possible to operate more precise treatment's condition. In order to evaluate the stability and performance due to differences in the submitted devices, we selected subjected AXA Abutment (Angled type) as the worst case representative device and conducted a fatigue test. Test results confirmed that there was no essential difference in product performance and stability.

3. Discussion

The subject device and reference devices have common in Indication for use, Design, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization type and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the proposed product is a straight type abutment so the fatigue test was performed as a representative of the worst case model with angle.

Based on the information in the submission, it is concluded that the substantially equivalent to the predicate device.

35

(14) AXA Abutment (Angled)

(14) AXA Abutment (Angled)	Subject Device	Reference Device
510(k) No.		K182448	K203808
Device Name	AXA Abutment(Angled)	Multi-unit Angled Abutment	Multi-unit Angled Abutment
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant Abutment
is intended to be surgically placed in the
maxillary or mandibular areas for the
purpose providing prosthetic support for
dental restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use
with ZrGEN Abutment are intended to be
sent to a MegaGen validated milling
center for manufacture.	The AnyRidge Octa 1 Implant System is
intended to be surgically placed in the
maxillary or mandibular arches for the
purpose of providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function in
the following situations and with the
clinical protocols:
-Delayed loading.
-Immediate loading when good
primary stability is achieved and with
appropriate occlusal loading. Larger
implants are dedicated for the molar
region.	The Multi-unit Abutment, Multi-unit
Angled Abutment is intended to be
surgically placed in the maxillary or
mandibular arches for the purpose
providing prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals.
Design
Diameter (Ø)	4.0, 5.0 mm	4.8 mm	4.8, 5.0 mm
Gingival Height	3.8, 5.8, 7.8 mm	2.3, 3.3, 4.3 mm	1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5
mm
Post Height	2.0, 4.0, 6.0 mm	2.2 mm	2.2, 3.9 mm
Total Length	6.4 ~ 10.85 mm	5.35 ~ 8.85mm	3.4 ~ 8.85 mm
Angulation	20°, 30°	17°, 30°	17°, 29°, 30°
Connection
Interface	Internal Hex,
Internal Non-Hex, Internal Octa,
Internal Non-Octa	Internal Octa,
Internal Non-Octa	Internal Hex,
Internal Non-Hex, Internal Octa,
Internal Non-Octa
Material	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)
Surface
Treatment	Anodizing, Machined	Machined	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Restoration
Type	Single & Multi	Single & Multi	Single & Multi
Principle of
Operation	This product is a pre-manufactured
prosthetic component connected to the
endosseous dental implant using the
screw and is intended for use as an aid in
prosthetic rehabilitation.	This product is a pre-manufactured
prosthetic component directly or
indirectly connected to the endosseous
dental implant using its threaded part or
screw for aid in prosthetic rehabilitation.	This product is a pre-manufactured
prosthetic component connected to the
endosseous dental implant using the
screw and is intended for use as an aid in
prosthetic rehabilitation.
Compatible
Implant
System	XPEED AnyRidge Internal Implant
System
AnyOne Internal Implant System
BLUDIAMOND Implant System	BLUDIAMOND Implant System	Xpeed AnyRidge Internal Implant
System
AnyOne Internal Implant System
BLUDIAMOND Implant System
Substantial Equivalence Discussion

1. Similarities

The subject device has the same characteristic for the followings compared to the reference devices.

Indication for use, Design, Connection Interface, Material, Surface Treatment, Single Use, Sterilization, Restoration type, Principle of Operation

2. Differences

The subject device has the different characteristic for the followings compared to the reference devices.

Diameter
The diameter (4.0 mm) of the subject device is smaller than the reference devices and other diameter (5.0 mm) is bigger than the reference devices. But, the variety of the size can be possible to operate more precise treatment to meet each patient s Therefore, it does not cause a matter in substantial equivalence.
Gingival Height, Post Height, Total Length,

The difference between the subject devices is that the total length, Post Height (6.0mm) and Gingival Height (5.7, 7.8 mm) are longer than the reference devices. In order to evaluate the stability and performance due to differences in the submitted devices,

36

the fatigue test was performed on the subject device to confirm the substantial equivalence. Also, the fatigue test was performed on the subjected AXA Abutment (Angled) as the representative model for the worst case with an angle to confirm the substantial equivalence. The test result supports that the subject device is substantially equivalent to the reference devices and the difference it not affecting the substantial equivalence.

- Angulation

The angles of the subject device are 20° angle is the same as the reference device. 20° angle is somewhat different from the reference device, but is within the range of the reference device, so no substantial equivalence issues arise.

3. Discussion

The subject device and reference devices have common in Indication for use, Design, Connection Interface, Material, Single Use, Sterilization, Restoration type and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the fatigue test was performed on the subjected AXA Abutment (Angled) as the representative model for the worst asse with an angle to confirm the substantial equivalence. The test result supports that the subject device is substantially equivalent to the reference devices and the difference it not affecting the substantial equivalence.

Based on the information in the submission, it is concluded that the substantially equivalent to the predicate device.

37

(15) Abutment Screw

	Subject Device	Reference Device
510(k) No.		K123988	K211812
Device Name	Abutment Screw	Abutment Screw	Abutment Screw
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant Abutment
is intended to be surgically placed in the
maxillary or mandibular areas for the
purpose providing prosthetic support for
dental restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use with
ZrGEN Abutment are intended to be sent
to a MegaGen validated milling center for
manufacture.	The AnyOne Internal Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas for
the purpose providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function.
Smaller implants (less than 6.0 mm) are
dedicated for immediate loading
when good primary stability is achieved
and with appropriate occlusal loading.
Larger implants are dedicated for the
molar region and are indicated for
delayed loading.	The BLUEDIAMOND IMPLANT System is
intended to be surgically placed in the
maxillary or mandibular molar
areas for the purpose ofproviding
prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. These implants
can be used where smaller implants
have failed.
Design	Image: Design of abutment screw	Image: Design of abutment screw	Image: Design of abutment screw
Diameter (Ø)	2.0, 2.1, 2.2 mm	2.3mm	2.2 mm
Total Length	7.9 ~ 12.7 mm	10.1 mm	9.9 mm
Material	Ti-6Al-4V ELI
(ASTM F136-13)	Ti-6Al-4V ELI
(ASTM F136-13)	Ti-6Al-4V ELI
(ASTM F136-13)
Surface
Treatment	Machined, Anodizing	Machined	Machined, Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle of
Operation	The Abutment Screw is used for
connecting abutment for each
Implant System. The lower part has
male screws depending on the
fixture system to be connected.	Abutment screw is used for is
used for connecting the
Abutment to the fixture.	The Abutment Screw is used for
connecting Fixture to Abutment or
Abutment to Cylinder.
Compatible
Implant
System	XPEED AnyRidge Internal Implant
System
AnyOne Internal Implant System
BLUDIAMOND Implant System	AnyOne Internal Implant System	BLUDIAMOND Implant System

1. Similarities

The subject device has the same characteristic for the followings compared to the reference devices.

Indication for use, Design, Material, Surface Treatment, Single Use, Sterilization, Principle of Operation

2. Differences

The subject device has the different characteristic for the followings compared to the reference device.

Diameter

Some of the diameters (2.0, 2.1 mm) of the subject device are smaller than the reference devices while other (2.2 mm) is same with the reference devices. The difference in size is very small, so the issue of substantive equivalence does not arise. And the variety of sizes allows for more precise treatment tailored to each patient's condition.

- Total Length

The Total Length of the subject device is slightly different with the reference devices but it does not cause a matter in substantial equivalence since the size differences are very minor.

3. Discussion

The subject device and reference devices have common in Indication for use, Design, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.

Based on the information based in submission, we conclude that the substantially equivalent to the reference devices.

38

(16) Cylinder Screw

	Subject Device	Reference Device
510(k) No.	-	K203808	K123988
Device Name	Cylinder Screw	Cylinder Screw	Flat Cylinder Screw
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for
Use Statement	The MegaGen Dental Implant Abutment
is intended to be surgically placed in the
maxillary or mandibular areas for the
purpose providing prosthetic support for
dental restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patients chewing function. All
digitally designed abutments for use
with ZrGEN Abutment are intended to be
sent to a MegaGen validated milling
center for manufacture.	The Multi-unit Abutment, Multi-unit
Angled Abutment is intended to be
surgically placed in the maxillary or
mandibular arches for the purpose
providing prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals.	The AnyOne Internal Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas for
the purpose providing prosthetic support
for dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function.
Smaller implants (less than 6.0 mm) are
dedicated for immediate loading
when good primary stability is achieved
and with appropriate occlusal loading.
Larger implants are dedicated for the
molar region and are indicated for
delayed loading.
Design
Diameter (Ø)	2.1 mm	2.0 mm	2.1 mm
Total Length	4.2 ~ 4.65 mm	3.4mm	5.9 mm
Material	Ti-6Al-4V ELI
(ASTM F136-13)	Ti-6Al-4V ELI
(ASTM F136-13)	Ti-6Al-4V ELI
(ASTM F136-13)
Surface
Treatment	Machined	Machined	Machined
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle of
Operation	Cylinder Screw is used for connecting
Multi-unit Abutment or Multi-unit
Angled Abutment or AXA Abutment to
Healing Cap, Temporary cylinder or EZ
Post Cylinder or CCM Cylinder.
It is made of Ti-6AI-4V-ELI and offered in
machined surface. The Cylinder Screw is
supplied non-sterile, to be sterilized by
the user according to the IFU and
intended for single use.	Cylinder Screw is used for
connecting Multi-unit Abutment or
Multi-unit Angled Abutment to
healing cap, Temporary Cylinder or
CCM Cylinder.	Flat Cylinder Screw is used for
connecting Abutment to healing cap
or Cylinder.
Compatible
Implant
System	XPEED AnyRidge Internal Implant
System
AnyOne Internal Implant System
BLUDIAMOND Implant System	XPEED AnyRidge Internal Implant
System
BLUDIAMOND Implant System
AnyOne Internal Implant System	AnyOne Internal Implant System
Substantial Equivalence Discussion
	Subject Device	Reference Device 1	Reference Device 2	Reference Device 3
510(k) No.		K182448	K103280	K133377
Device Name	Crown Screw	Multi-unit Abutment
Screw	Rosen Screw	Omniqrip Clinical Screw
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	BHI IMPLANTS LTD	Nobel Biocare
Indications for
Use Statement	The MegaGen Dental Implant
Abutment is intended to be
surgically placed in the
maxillary or mandibular areas
for the purpose providing
prosthetic support for dental
restorations (Crown, bridges,
and overdentures) in partially
or fully edentulous individuals.
It is used to restore a patients
chewing function. All digitally
designed abutments for use
with ZrGEN Abutment are
intended to be sent to a
MegaGen validated milling
center for manufacture.	The AnyRidge Octa 1 Implant
System is intended to be
surgically placed in the
maxillary or mandibular
arches for the purpose of
providing prosthetic support
for dental restorations
(Crown, bridges, and
overdentures) in partially or
fully edentulous individuals.
It is used to restore a
patient's chewing function in
the following situations and
with the clinical protocols:
-Delayed loading.
-Immediate loading when
good primary stability is
achieved and with
appropriate occlusal loading.
Larger implants are
dedicated for the molar
region.	The Bhdental Implant System
is indicated for use in surgical
and restorative applications
for placement in the bone of
the upper or lower jaw to
provide support for prosthetic
devices, such as artificial
teeth, in order to restore the
patient chewing function. The
Bhdental Implant is also
indicated for immediate
loading when good primary
stability is achieved and with
appropriate occlusal loading.	The NobelProcera Angulated
Screw Channel Abutment
Replace are premanufactured
prosthetic components
directly connected to
endosseous dental implants
and are intended for use as an
aid in prosthetic
rehabilitation.
Design
Diameter (Ø)	2.1, 2.3, 2.4 mm	2.1 mm	1.4, 1.6, 1.72 mm	Unknown
Total Length	4.65, 5.2, 7.2 mm	7.0 mm	Unknown	Unknown
Material	Ti-6Al-4V ELI
(ASTM F136-13)	Ti-6Al-4V ELI
(ASTM F136-13)	Ti-6Al-4V ELI
(ASTM F136-13)	Ti-6Al-4V ELI
(ASTM F136-13)
Surface
Treatment	Machined	Machined	Machined, Anodizing	Machined, Anodizing
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle of
Operation	The Crown Screw is a
prosthetic component
connected to abutment and
intended for use as an aid in
prosthetic rehabilitaion. It is
made of Ti-6AI-4V-ELI and
offered in machined surface.
The crown Screw is supplied
non-sterile, to be sterilized by
the user according to the IFU
and intended for single use.	Multi-unit Abutment Screw
is used for connecting Multi-
unit Abutment or Multi-unit
Angled Abutment to the
fixture.	The Bhdental Implant System
is indicated for use in surgical
and restorative applications
for placement in the bone of
the upper or lower jaw to
provide support for prosthetic
devices, such as artificial
teeth, in order to restore the
patient chewing function.	The NobelProcera Angulated
Screw Channel Abutment
Replace are premanufactured
prosthetic components
directly connected to
endosseous dental implants
and are intended for use as an
aid in prosthetic
rehabilitation.
Compatible
Implant
System	XPEED AnyRidge Internal
Implant System
BLUDIAMOND Implant
System
AnyOne Internal Implant
System	BLUDIAMOND Implant
System	N/A	N/A
Substantial Equivalence Discussion
1. Similarities
The subject device has the same characteristic for the followings compared to the reference devices.

Indication for use, Design, Material, Surface Treatment, Single Use, Sterilization, Principle of Operation | | | | |

1. Similarities

The subject device has the same characteristic for the followings compared to the reference devices.

Indication for use, Design, Diameter, Material, Surface Treatment, Single Use, Sterilization, Principle of Operation

2. Differences

The subject device has the different characteristic for the followings compared to the reference devices.

- Total Length

The Total Length of subject device is slightly different with the reference devices. The Total Length of slightly different with the reference devices. Therefore, it does a matter in substantial equivalence since this size difference is very minor.

3. Discussion

The subject device and reference devices have common in all the items except the Total Length difference is explained not affecting on the substantial equivalence.

Based on the information based in submission, we conclude that the substantially equivalent to the reference devices.

39

Differences

The subject device has the different characteristic for the followings compared to the reference devices. - Diameter

40

The Diameter (2.1mm) of the subject device is same with the dimeter of reference device 1 and the others are different. And the Diameter of reference device 3 is unknown. The differences are very minor with the reference it does not cause a matter in substantial equivalence.

Total Length

The Total lengths of reference devices 1, 2 are unknown. The total length (7.2 mm) of the subject device is slightly different with the reference device 1. But the total length includes the connection length of each implant system and therefore does not affect substantial equivalence.

3. Discussion

The subject device and reference devices have common in Indication for use, Design, Material, Single Use, Sterilization and Principle of Operation. The Diameter and Total length differences are explained not affecting on the substantial equivalence.

Based on the information based in submission, we conclude that the substantially equivalent to the reference devices.

41

8. Summary of Non-Clinical Testing

The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.

Biocompatibility

The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. All of the subject device materials and manufacturing have been previously cleared in K182448 and K231967. Therefore, no additional biocompatibility testing was performed in this submission.

Sterilization validation

The Scan Healing Abutment is provided as sterile device is cleaned and sterilized by gamma irradiation. The final sterilization process, v-ray irradiation is commissioned to an outside in it. The Sterility Assurance Level (SAL) shall comply with EN556, that is the Highest Assurance Level (Class 3), 10-6. ysterilization doze shall be set based on this and for y-sterilization doze and irradiation shall be determined in accordance with ISO11137-Method I.

The subject devices excluding the sterile device are supplied in non-sterile state. Sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 17665-1, 2 to verify the sterility assurance level (10").

Performance (Physical Properties) Test

The bench tests have been performed in accordance with 'ISO 14801' and the recommendations of 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to evaluate the performance of the subject devices and the test results met the pre-set criteria.

MR Compatibility

Non-clinical worst-case MRI review was performed to evaluate the metallic MegaGen Dental Implant system as MR Conditional in the MRI environment using scientific rationale and published literature (Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.

Summary of Clinical Testing

No clinical studies are submitted.

Conclusion

Based on the information provided in this premarket notification, We, MegaGen Implant Co., Ltd. conclude that the MegaGen Dental Implant Abutment is substantially equivalent to the predicate device as herein.