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.

Device Description

The submission includes descriptions for the following devices: 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, and Crown Screw. Each description details the intended use, material, surface treatment, sterilization, single use status, dimensions, and compatible implant systems.

AI/ML Overview

The provided document, a 510(k) premarket notification from MegaGen Implant Co., Ltd. for their "MegaGen Dental Implant Abutment" device, focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving that the device meets specific acceptance criteria through a standalone study.

For medical devices, especially those going through the 510(k) pathway, acceptance criteria are typically based on showing that the new device performs as safely and effectively as a legally marketed predicate device. The "study" proving this is primarily a non-clinical performance testing (bench testing) and a comparison to predicate devices. Clinical studies are often not required for 510(k) submissions, as explicitly stated in this document ("No clinical studies are submitted.").

Therefore, the acceptance criteria are implicitly defined by the performance characteristics of the predicate devices and general standards (like ISO 14801 for dental implants) as outlined in the "Summary of Non-Clinical Testing" section. The device performance is demonstrated through a comparative analysis to these predicates and the results of the bench testing.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, the "acceptance criteria" for the subject device are fundamentally its demonstration of substantial equivalence to predicate devices, meaning it performs as safely and effectively. The "reported device performance" is a direct comparison to the predicate devices and adherence to relevant standards.

The document provides extensive comparison tables for each component of the MegaGen Dental Implant Abutment system against its predicate and reference devices. Below is a representative excerpt from these tables, focusing on a few key components to illustrate the comparison:

Example: Scan Healing Abutment

Characteristic	Acceptance Criteria (Predicate/Reference K110955, K220562)	Reported Device Performance (MegaGen Dental Implant Abutment - Scan Healing Abutment)
Indications for Use	Providing prosthetic support for dental restorations in partially or fully edentulous individuals to restore chewing function. Scan Healing Abutment is intended for use on endosseous dental implants as an aid in prosthetic rehabilitation.	Identical. Intended to be surgically placed in maxillary or mandibular areas for prosthetic support of dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals to restore chewing function. Also a scannable for impression intraoral without removal.
Material	Ti-6A1-4V ELI (ASTM F136-13) (for predicate and reference devices)	Ti-6A1-4V ELI (ASTM F136-13)
Total Length	Predicate: 8.4 ~ 14.4 mm; Reference: 6.9 ~ 11.85mm	6.9 ~ 11.9 mm
Surface Treatment	Predicate: Machined; Reference: Anodizing	Anodizing
Sterilization	Gamma sterilization (for predicate and reference devices)	Gamma sterilization
Principle of Operation	Fastened into female screw of dental implant, support gingival shaping. Reference also scannable.	Fastened into female screw of dental implant, support gingival shaping, scannable for impression intraoral without removal.

Summary of Device Performance (Based on "Substantial Equivalence Discussion" sections for all components):

The subject device is deemed substantially equivalent to its predicate/reference devices across all listed components (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).

Any identified differences in characteristics (e.g., specific dimensions like diameter, gingival height, post height, total length, or surface treatment for some components) are explicitly discussed and concluded not to affect substantial equivalence. This is often supported by arguing that the differences are minor, fall within the range of cleared devices, allow for more precise treatment, or are supported by bench testing (e.g., fatigue tests for worst-case scenarios).

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific sample sizes for test sets in the context of clinical data, as no clinical studies were submitted.

For non-clinical testing (bench tests), the document states:

"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."
For ZrGEN Abutment, AXA Abutment (Angled type), and other potentially "worst-case" scenarios, fatigue tests were conducted to demonstrate performance and stability.

The data provenance is pre-market non-clinical testing data generated by the manufacturer. The country of origin for the manufacturing and testing is Republic of Korea (MegaGen Implant Co., Ltd. is based in Daegu, Republic of Korea). The data is prospective in the sense that it was specifically generated for this 510(k) submission to demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable (N/A) as no clinical studies were conducted or submitted. For non-clinical bench testing, "ground truth" is established by adherence to recognized standards (like ISO 14801) and established testing methodologies, not typically by expert consensus of medical professionals on a test set.

4. Adjudication Method for the Test Set

This information is N/A as no clinical studies with human readers or image interpretation were conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement

This information is N/A as no clinical studies were conducted, and certainly no MRMC studies involving human readers, as this is a physical dental implant component, not an AI or imaging device that would typically involve human-in-the-loop performance evaluation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is N/A as the device is a physical dental implant abutment, not a software algorithm.

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is:

Performance specifications derived from legally marketed predicate devices.
Adherence to recognized international standards (e.g., ISO 14801 for mechanical properties, ISO 10993-1 for biocompatibility, ISO 11137 for sterilization) for manufacturing and material properties.
Results of non-clinical bench testing to confirm physical and mechanical performance characteristics.

There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of a clinical study since none were performed.

8. The Sample Size for the Training Set

This information is N/A. The device is a physical product, not an AI/ML model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is N/A as there is no training set for a physical device.

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.

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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

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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)

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 PostAbutment; 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

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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 HealingAbutment	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 ImplantSystem	Device Name	510(k)Number	Connection	Diameter (mm)
MegaGenImplant Co.,Ltd.	XPEED AnyRidgeInternal ImplantSystem	XPEED AnyRidgeInternal Fixture	K110955 K122231 K123870 K140091	InternalHex	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
TemporaryAbutment	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 ImplantSystem	Device Name	510(k)Number	Connection	Diameter (mm)
MegaGenImplant Co.,Ltd.	XPEED AnyRidgeInternal ImplantSystem	XPEED AnyRidgeInternal Fixture	K110955 K122231 K123870 K140091	InternalHex	4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 7.9, 8.4
	BLUEDIAMONDIMPLANT System	BLUEDIAMONDIMPLANT	K182448 K211812	InternalOcta	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
TemporaryCylinder	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 CapScrew	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
MillingAbutment	XPEED AnyRidge Internal Implant System$\varnothing$ 4.0 x 22.4mm

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Manufacturer	Compatible ImplantSystem	Device Name	510(k)Number	Connection	Diameter (mm)
MegaGenImplant Co.,Ltd.	XPEED AnyRidgeInternal ImplantSystem	XPEED AnyRidgeInternal Fixture	K110955 K122231 K123870 K140091	InternalHex	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 SystemØ 5.0 x 12.9mmPost Height: 5.5mm
EZ PostAbutment/Extra EZ PostAbutment	BLUEDIAMOND IMPLANT SystemØ 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, 14.85mmØ 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, 16.35mmPost Height: 4.0, 7.0 mm

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

Manufacturer	Compatible ImplantSystem	Device Name	510(k)Number	Connection	Diameter (mm)
MegaGenImplant Co.,Ltd.	XPEED AnyRidgeInternal ImplantSystem	XPEED AnyRidgeInternal Fixture	K110955 K122231 K123870 K140091	InternalHex	4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 7.9, 8.4
MegaGenImplant Co.,Ltd.	BLUEDIAMONDIMPLANT System	BLUEDIAMONDIMPLANT	K182448 K211812	InternalOcta	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 mmPost 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).

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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
ZrGENAbutment	XPEED AnyRidge Internal Implant SystemØ 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 SystemØ 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
	CommonØ 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 ImplantSystem	Device Name	510(k)Number	Connection	Diameter (mm)
MegaGenImplant Co.,Ltd.	XPEED AnyRidgeInternal ImplantSystem	XPEED AnyRidgeInternal Fixture	K110955 K122231 K123870 K140091	InternalHex	4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 7.9, 8.4
MegaGenImplant Co.,Ltd.	BLUEDIAMONDIMPLANT System	BLUEDIAMONDIMPLANT	K182448 K211812	InternalOcta	3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,5.5, 5.6, 6.0, 6.5, 7.0

*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 mmBLUEDIAMOND IMPLANT System$\varnothing$ 4.8 x 14.8, 13.8 mmAnyOne 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:

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Manufacturer	Compatible ImplantSystem	Device Name	510(k)Number	Connection	Diameter (mm)
MegaGenImplant Co.,Ltd.	XPEED AnyRidgeInternal ImplantSystem	XPEED AnyRidgeInternal Fixture	K123870 K140091	InternalHex	4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 7.9, 8.4
	AnyOne InternalImplant System	AnyOne InternalFixture	K123988	Internal Hex	3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,7.3, 7.8, 8.3
	BLUEDIAMONDIMPLANT System	BLUEDIAMONDIMPLANT	K182448	InternalOcta	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-unitAngledAbutment	XPEED AnyRidge Internal Implant SystemØ 4.8 x 7.4, 7.9, 8.4, 8.9 mmBLUEDIAMOND IMPLANT SystemØ 4.8 x 8.35, 9.35, 9.85, 10.85 mmAnyOne Internal Implant SystemØ 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 ImplantSystem	Device Name	510(k)Number	Connection	Diameter (mm)
MegaGenImplant Co.,Ltd.	XPEED AnyRidgeInternal ImplantSystem	XPEED AnyRidgeInternal Fixture	K123870 K140091	InternalHex	4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 7.9, 8.4
	AnyOne InternalImplant System	AnyOne InternalFixture	K123988	Internal Hex	3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,7.3, 7.8, 8.3
	BLUEDIAMONDIMPLANT System	BLUEDIAMONDIMPLANT	K182448	InternalOcta	3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,5.5

*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.

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The dimensions of AXA Abutment (Straight) are follows:

Device	Component
AXA Abutment(Straight)	XPEED AnyRidge Internal Implant SystemØ 4.0, 5.0 x 11.05, 12.05, 13.05, 15.05, 17.05, 19.05 mmBLUEDIAMOND IMPLANT SystemØ 4.0, 5.0 x 12.10, 13.10, 14.10, 16.10, 18.10, 20.10 mmAnyOne Internal Implant SystemØ 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 ImplantSystem	Device Name	510(k)Number	Connection	Diameter (mm)
MegaGenImplant Co.,Ltd.	XPEED AnyRidgeInternal ImplantSystem	XPEED AnyRidgeInternal Fixture	K110955 K122231 K123870 K140091	InternalHex	4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 7.9, 8.4
	AnyOne InternalImplant System	AnyOne InternalFixture	K123988	Internal Hex	3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,7.3, 7.8, 8.3
	BLUEDIAMONDIMPLANT System	BLUEDIAMONDIMPLANT	K182448 K211812	InternalOcta	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 SystemØ 4.0, 5.0 x 6.4, 8.4, 10.4 mm
	BLUEDIAMOND IMPLANT SystemØ 4.0, 5.0 x 6.85, 8.85, 10.85 mm
	AnyOne Internal Implant SystemØ 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 ImplantSystem	Device Name	510(k)Number	Connection	Diameter (mm)
MegaGenImplant Co.,Ltd.	XPEED AnyRidgeInternal ImplantSystem	XPEED AnyRidgeInternal Fixture	K110955 K122231 K123870 K140091	InternalHex	4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 7.9, 8.4
	AnyOne InternalImplant System	AnyOne InternalFixure	K123988	Internal Hex	3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,7.3, 7.8, 8.3
	BLUEDIAMONDIMPLANT System	BLUEDIAMONDIMPLANT	K182448 K211812	InternalOcta	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.

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The dimensions of Abutment Screw are follows:

Device	Component
Abutment Screw	XPEED AnyRidge Internal Implant SystemØ 2.0 x 8.5, 9.45, 11.45 mmBLUEDIAMOND IMPLANT SystemØ 2.2 x 9.9, 7.9 mmAnyOne Internal Implant SystemØ 2.1 x 9.6, 10.6, 12.6 mm

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

Manufacturer	Compatible ImplantSystem	Device Name	510(k)Number	Connection	Diameter (mm)
MegaGenImplant Co.,Ltd.	XPEED AnyRidgeInternal ImplantSystem	XPEED AnyRidgeInternal Fixture	K110955 K122231 K123870 K140091	InternalHex	4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 7.9, 8.4
	AnyOne InternalImplant System	AnyOne InternalFixture	K123988	Internal Hex	3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,7.3, 7.8, 8.3
	BLUEDIAMONDIMPLANT System	BLUEDIAMONDIMPLANT	K182448 K211812	InternalOcta	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, 7.0mmØ 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

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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 forUse Statement	The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for usewith ZrGEN Abutment are intended to besent to a MegaGen validated millingcenter for manufacture.	The AnyRidge Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than Ø6.0 mm) arededicated for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molarregion and are indicated for delayedloading.	Scan Healing Abutment is intended foruse on endosseous dental implants inthe edentulous or partially edentulousmaxilla or mandible, as an aid inprosthetic 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
ConnectionInterface	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)
SurfaceTreatment	Anodizing	Machined	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization
Shelf-life	5 years	5 years	5 years
Principle ofOperation	The Scan Healing Abutment is fastenedinto the female screw of dental implantand support the gingival shaping. And itis a scannable that can help with theimpression intraoral without removal.	The Healing Abutment is fastened intothe female screw of dental implant andsupport the gingival shaping.	The Scan Healing Abutment is fastenedinto the female screw of dental implantand support the gingival shaping. And itis a scannable that can help with theimpression intraoral without removal.
CompatibleImplantSystem	XPEED AnyRidge Internal Implant System	XPEED AnyRidge Internal Implant System	XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND 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.

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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.

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(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 forUse Statement	The MegaGen Dental ImplantAbutment is intended to besurgically placed in the maxillaryor mandibular areas for thepurpose providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals. It isused to restore a patientschewing function. All digitallydesigned abutments for usewith ZrGEN Abutment areintended to be sent to aMegaGen validated millingcenter for manufacture.	The AnyRidge Internal ImplantSystem is intended to besurgically placed in themaxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patientschewing function. Smallerimplants (less than 6.0 mm) arededicated for immediateloading when good primarystability is achieved and withappropriate occlusal loading.Larger implants are dedicatedfor the molar region and areindicated for delayed loading.	The AnyRidge Octa 1Implant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function in thefollowing situation and withthe clinical protocols:- Immediate loading whengood primary stability isachieved and withappropriate occlusalloading.	The Multi-unit Abutment,Multi-unit Angled Abutmentis intended to be surgicallyplaced in the maxillary ormandibular arches for thepurpose providing prostheticsupport for dentalrestorations (Crown, bridges,and overdentures) inpartially or fully edentulousindividuals.
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
GingivalHeight	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
ConnectionInterface	Hex, Non-HexOcta, 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)
SurfaceTreatment	Machined, Anodizing	Machined	Machined, Anodizing	Anodizing
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Temporary Abutment is asuperstructure which isconnected to the Fixtures orRegular Abutment using theAbutment Screw.It is used to provide support forprovisional restoration.	The Temporary Cylinder is asuperstructure which isconnected to the Abutmentusing the Screw.It is used to provide support forprovisional restoration.	The Temporary Abutment isa superstructure which isconnected to the Fixturesusing the Screw.It is used to provide supportfor provisional restoration.	This product is a pre-manufactured prostheticcomponent directly orindirectly connected to theendosseous dental implantusing its threaded part orscrew for aid in prostheticrehabilitation.
CompatibleImplantSystem	XPEED AnyRidge InternalImplant SystemBLUEDIAMOND IMPLANTSystem	XPEED AnyRidge InternalImplant System	BLUEDIAMOND IMPLANTSystem	XPEED AnyRidge Internal ImplantSystemAnyOne Internal Implant SystemBLUEDIAMOND 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

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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.

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(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 forUse Statement	The MegaGen Dental ImplantAbutment is intended to besurgically placed in themaxillary or mandibular areasfor the purpose providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulousindividuals. It is used torestore a patients chewingfunction. All digitally designedabutments for use withZrGEN Abutment areintended to be sent to aMegaGen validated millingcenter for manufacture.	The AnyRidge InternalImplant System is intended tobe surgically placed in themaxillary or mandibularmolar areas for the purposeproviding prosthetic supportfor dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals. Itis used to restore a patient'schewing function. Smallerimplants (less than Ø6.0 mm)are dedicated for immediateloading when good primarystability is achieved and withappropriate occlusal loading.Larger implants are dedicatedfor the molar region and areindicated for delayed loading.	The Multi-unit Abutment,Multi-unit Angled Abutment isintended to be surgicallyplaced in the maxillary ormandibular arches for thepurpose providing prostheticsupport for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.	The AnyOne Internal ImplantSystem is intended to besurgically placed in themaxillary or mandibularmolar areas for the purposeproviding prosthetic supportfor dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals.It is used to restore apatient's chewing function.Smaller implants (less than6.0 mm) are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusal loading..Larger implants arededicated for the molarregion and are indicated fordelayed 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
ConnectionInterface	Internal Non-Hex	Internal Non-Hex	Internal Octa,Internal Non-Octa	Internal Octa, Non-OctaInternal 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)
SurfaceTreatment	Machined	Machined	Machined	Machined
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	Temporary Cylinder is used inconjunction with Multi-unitAbutment to provide supportfor provisional restoration.	Temporary Cylinder is used inconjunction with Multi-unitAbutment to provide supportfor provisional restoration.	Temporary Cylinder is used inconjunction with Multi-unit(Angled) Abutment (N type) toprovide support forprovisional restoration.	Temporary Cylinder is usedin conjunction with OctaAbutment and Multi-unit(Angled) Abutment (S type)to provide support forprovisional restoration.
CompatibleImplantSystem	XPEED AnyRidge InternalImplant SystemBLUDIAMOND ImplantSystem	XPEED AnyRidge InternalImplant System	XPEED AnyRidge InternalImplant SystemAnyOne Internal ImplantSystemBLUDIAMOND Implant System	AnyOne Internal ImplantSystem
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

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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.

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(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 forUse Statement	The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for usewith ZrGEN Abutment are intended to besent to a MegaGen validated millingcenter for manufacture.	The AnyRidge Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than Ø6.0 mm) arededicated for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molarregion and are indicated for delayedloading.	The AnyOne™ Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than Ø6.0 mm) arededicated for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molarregion and are indicated for delayedloading.
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 ofOperation	The Comfort Cap is used for protecting aSolid Abutment after taking impression,and minimizing irritation to tongue andoral mucosa. It easily makes a temporarycrown by resin build up.	The Comfort Cap is used for protecting aSolid Abutment after taking impression,and minimizing irritation to tongue andoral mucosa. It easily makes a temporarycrown by resin build up.	The Comfort Cap is used for protecting aSolid Abutment after taking impression,and minimizing irritation to tongue andoral mucosa. It easily makes a temporarycrown by resin build up.
CompatibleImplantSystem	XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND IMPLANT System	XPEED AnyRidge Internal Implant System	AnyOne Internal Implant System
Substantial Equivalence Discussion
1. SimilaritiesThe 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.
Indicationsfor UseStatement	The MegaGen Dental ImplantAbutment is intended to besurgically placed in themaxillary or mandibular areasfor the purpose providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patientschewing function. All digitallydesigned abutments for usewith ZrGEN Abutment areintended to be sent to aMegaGen validated millingcenter for manufacture.	The AnyRidge Internal Implant System is intended to besurgically placed in the maxillary or mandibular molar areasfor the purpose providing prosthetic support for dentalrestorations (Crown, bridges, and overdentures) in partiallyor fully edentulous individuals. It is used to restore apatient's chewing function. Smaller implants (less than Ø6.0mm) are dedicated for immediate loading when goodprimary stability is achieved and with appropriate occlusalloading. Larger implants are dedicated for the molar regionand are indicated for delayed loading.		The Multi-unit Abutment,Multi-unit Angled Abutmentis intended to be surgicallyplaced in the maxillary ormandibular arches for thepurpose providing prostheticsupport for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulousindividuals.
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
ConnectionInterface	Two-piece Healing Cap(with titanium alloy screw)	Two-piece Healing Cap(with titanium alloyscrew)	One-piece	Two-piece Healing Cap(with titanium alloyscrew)
Material	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)	POM	Ti-6Al-4V ELI(ASTM F136-13)
SurfaceTreatment	Machined, Anodizing	Machined	Non-Sterile	Machined
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Healing Cap is intended tobe used during intra-oral softtissue healing to protect theMulti-unit Abutments andMulti-unit Angled Abutments orAXA Abutment (Straight,Angled) and prepare the softtissue for the prostheticprocedure (temporary and finalrestoration). It is a two-piecetype, connected to theabutment with Cylinder Screw.The Healing Cap is a temporarycomponent used for soft tissuehealing.	Healing Cap is used forprotecting Octa Abutmentand minimizing irritation totongue and oral mucosaduring period of gingivalhealing.	The Comfort Cap is used forprotecting a Solid Abutmentafter taking impression, andminimizing irritation totongue and oral mucosa. Iteasily makes a temporarycrown by resin build up.	Healing Cap is used forprotecting Multi-unitAbutment or Multi-unitAngled Abutment andminimizing irritation totongue and oral mucosaduring period of gingivalhealing.
CompatibleImplantSystem	XPEED AnyRidge InternalImplant SystemAnyOne Internal ImplantSystemBLUEDIAMOND IMPLANTSystem	XPEED AnyRidge InternalImplant System	XPEED AnyRidge InternalImplant System	XPEED AnyRidge InternalImplant SystemAnyOne Internal ImplantSystemBLUEDIAMOND IMPLANTSystem

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.
Indicationsfor UseStatement	The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for usewith ZrGEN Abutment are intended to besent to a MegaGen validated millingcenter for manufacture.	The AnyOne™ Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prostheticsupport for dental restorations (Crown,bridges, and overdentures) in partially orfully edentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than Ø6.0 mm) arededicated for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molarregion and are indicated for delayedloading.	The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous 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)
SurfaceTreatment	Machined	Machined	Machined
Single Use	Yes	No	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	Healing Cap Screw is used for connectingAXA Abutment (Straight) or AXAAbutment (Angled) to Healing Cap. It ismade of Ti-6AI-4V-ELI and offered inmachined surface. The Healing Cap BodyScrew is supplied non-sterile, to besterilized by the user according to theIFU and intended for single use.	Flat Cylinder Screw is used forconnecting Abutment or Healing cap orCylinder.	Cylinder Screw is used for connectingMulti-unit Abutment or Multi-unitAngled Abutment to Healing Cap,Temporary cylinder or CCM Cylinder.
CompatibleImplantSystem	XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND IMPLANT System	XPEED AnyRidge Internal Implant System	XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND 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 forUse Statement	The MegaGen Dental ImplantAbutment is intended to be surgicallyplaced in the maxillary or mandibularareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for usewith ZrGEN Abutment are intended tobe sent to a MegaGen validated millingcenter for manufacture.	The Xpeed AnyRidge Internal ImplantSystem is intended to be surgically placedin the maxillary or mandibular molarareas for the purpose providingprosthetic support for dental restorations(Crown, bridges, and overdentures) inpartially or fully edentulous individuals. Itis used to restore a patients chewingfunction. Smaller implants (less than 6.0mm) are dedicated for immediate loadingwhen good primary stability is achievedand with appropriate occlusal loading.Larger implants arededicated for the molar region and areindicated for delayed loading.	The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function inthe following situation and with theclinical protocols:- Immediate loading when good primarystability is achieved and with appropriateocclusal 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 ofOperation	This product is a superstructure whichis connects with the fixtures using theAbutment Screw. It replaces thefunctions of the missing teeth as adental abutment.	This product is a superstructure which isconnects with the fixtures using theAbutment Screw. It replaces thefunctions of the missing teeth as adental abutment.	This product is a superstructure which isconnects with the fixtures using theAbutment Screw. It replaces thefunctions of the missing teeth as adental abutment.
CompatibleImplant System	XPEED AnyRidge Internal ImplantSystem	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 forUse Statement	The MegaGen Dental ImplantAbutment is intended to be surgicallyplaced in the maxillary or mandibularareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for usewith ZrGEN Abutment are intended tobe sent to a MegaGen validated millingcenter for manufacture.	The Xpeed AnyRidge Internal ImplantSystem is intended to be surgically placedin the maxillary or mandibular molarareas for the purpose providingprosthetic support for dental restorations(Crown, bridges, and overdentures) inpartially or fully edentulous individuals. Itis used to restore a patients chewingfunction. Smaller implants (less than 6.0mm) are dedicated for immediate loadingwhen good primary stability is achievedand with appropriate occlusal loading.Larger implants arededicated for the molar region and areindicated for delayed loading.	The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function inthe following situation and with theclinical protocols:- Immediate loading when good primarystability is achieved and with appropriateocclusal 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
ConnectionInterface	Hex, Non-hexOcta, 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)
SurfaceTreatment	Anodizing	Anodizing	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	This product is a superstructure whichis connects with the fixtures using theAbutment Screw. It replaces thefunctions of the missing teeth as adental abutment.	This product is a superstructure which isconnects with the fixtures using theAbutment Screw. It replaces thefunctions of the missing teeth as a dentalabutment.	This product is a superstructure which isconnects with the fixtures using theAbutment Screw. It replaces thefunctions of the missing teeth as a dentalabutment.
CompatibleImplant System	XPEED AnyRidge Internal ImplantSystemBLUEDIAMOND IMPLANT System	XPEED AnyRidge Internal Implant System	BLUEDIAMOND IMPLANT System
		Substantial Equivalence Discussion
1. SimilaritiesThe 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.2. DifferencesThe subject device has the different characteristic for the followings compared to the predicate device and reference device.- Gingival HeightSome of the Gingival Height (5mm) is longer than the predicate device and reference device while other Gingival Heights are samewith the predicate device and reference device. The difference in size is very small, so the issue of substantive equivalence doesnot arise. Also, In order to evaluate the stability and performance due to differences in the submitted devices, we selectedsubjected AXA Abutment (Angled type) as the worst case representative device and conducted a fatigue test. Test resultsconfirmed that there was no essential difference in product performance and stability.- Total LengthThe Total Length of the subject device is slightly different with the predicate device and reference device. But, the variety of thesize can be possible to operate more precise treatment to meet each patient's condition. Therefore, it does not cause a matter insubstantial equivalence.3. Discussion
The subject device and reference device have common in Indication for use, Design, Diameter, Post height, Angulation, ConnectionInterface, 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 forUse Statement	The MegaGen Dental ImplantAbutment is intended to be surgicallyplaced in the maxillary or mandibularareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for usewith ZrGEN Abutment are intended tobe sent to a MegaGen validated millingcenter for manufacture.	The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function in thefollowing situation and with the clinicalprotocols:- Immediate loading when good primarystability is achieved and with appropriateocclusal loading	The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous 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
ConnectionInterface	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)
SurfaceTreatment	Machined, Anodizing	Anodizing	Machined
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	EZ Post Cylinder is used in conjunctionwith Multi-unit Abutment or AXAAbutment to provide support forprovisional restoration.	EZ Post Cylinder is used in conjunctionwith Octa Abutment to provide supportfor cement and screw type finalprosthesis. EZ Post Cylinder and OctaAbutment are connected by combiningthe female screw on the top of the OctaAbutment and Cylinder Screw.	The EZ Post Cylinder is used inconjunction with Regular Abutment toprovide support for cement and screwtype final prosthesis. It is connected tothe Abutment using Abutment Screw.
CompatibleImplantSystem	XPEED AnyRidge Internal ImplantSystemBLUDIAMOND IMPLANT SystemAnyOne Internal Implant System	BLUDIAMOND IMPLANT System	XPEED AnyRidge Internal ImplantSystemBLUDIAMOND IMPLANT SystemAnyOne 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 forUse Statement	The MegaGen Dental ImplantAbutment is intended to besurgically placed in themaxillary or mandibular areasfor the purpose providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patientschewing function. All digitallydesigned abutments for usewith ZrGEN Abutment areintended to be sent to aMegaGen validated millingcenter for manufacture.	The Xpeed AnyRidge InternalImplant System is intendedto be surgically placed in themaxillary or mandibularmolar areas for the purposeproviding prosthetic supportfor dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals.It is used to restore apatients chewing function.Smaller implants (less than6.0 mm) are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusal loading.Larger implants arededicated for the molarregion and are indicated fordelayed loading.	The AnyOne™ InternalImplant System is intendedto be surgically placed in themaxillary or mandibularmolar areas for the purposeproviding prosthetic supportfor dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals.It is used to restore apatient's chewing function.Smaller implants (less thanØ6.0 mm) are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusal loading.Larger implants arededicated for the molarregion and are indicated fordelayed loading.	The TiGEN Abutment, ZrGENAbutment and Scan HealingAbutment are intended foruse on endosseous dentalimplants in the edentulousor partially edentulousmaxilla or mandible, as anaid in prostheticrehabilitation.For TiGEN Abutment andZrGEN Abutment, all digitallydesigned abutments for usewith TiGEN Abutment andZrGEN Abutment areintended to be sent to aMegaGen-validated millingcenter for manufacture.
Titanium basecomponentrepresentativeimage	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) ofthe titanium basecomponent	4.0, 4.5, 4.8, 5.0, 5.5, 6.0mm	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 ofthe titanium basecomponent	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 thetitanium basecomponent	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°)
ConnectionInterface	Internal Conical Connection	Internal ConicalConnection	Internal ConicalConnection	Internal ConicalConnection
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)
SurfaceTreatment	Machined	Anodizing	Machined	Machined
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-Sterile	Non-Sterile	Non-Sterile	Gamma sterilization
Principle ofOperation	The ZrGEN Abutment is used toprovide support for customizedprosthetic restorations such ascopings and crowns using FDA-clear Zirconia block. The ZrGENAbutment itself is not to bemachined but used as it is. TheZirconia top-half of ZrGENAbutments are intended to besent to a MegaGen-validatedmilling center for manufacture	This product is asuperstructure which isconnects with the fixturesusing the Abutment Screw. Itreplaces the functions of themissing teeth as a dentalabutment.	The ZrGEN Abutment is usedto provide support forcustomized prostheticrestorations such as copingsand crowns using FDA-clearZirconia block. The ZrGENAbutment itself is not to bemachined but used as it is.The Zirconia top-half ofZrGEN Abutments areintended to be sent to aMegaGen-validated milling	The ZrGEN Abutment is usedto provide support forcustomized prostheticrestorations such as copingsand crowns using FDA-clearZirconia block. The ZrGENAbutment itself is not to bemachined but used as it is.The Zirconia top-half ofZrGEN Abutments areintended to be sent to aMegaGen-validated milling
	allowable range of designparameters provided byMegaGen.		center for manufacture andmust be designed with theallowable range of designparameters provided byMegaGen.	center for manufacture andmust be designed with theallowable range of designparameters provided byMegaGen.
CompatibleImplant System	XPEED AnyRidge InternalImplant SystemAnyOne Internal ImplantSystemBLUEDIAMOND IMPLANTSystem	XPEED AnyRidge InternalImplant System	AnyOne Internal ImplantSystem	XPEED AnyRidge InternalImplant SystemAnyOne Internal ImplantSystemBLUEDIAMOND IMPLANTSystem
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 ofOperation
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 subjectdevice 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 otherpost 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 postheight of reference device. It does not cause a matter in substantial equivalence since this size difference is very minor, and thevariety 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 subjectdevice is longer then the reference devices. But the smaller total length (4.5mm) is not a worst case of performance testing and thetotal 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 AXAAbutment (Angled type) as the worst case representative device and conducted a fatigue test. Test results confirmed that there wasno 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 casemodel 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 forUse Statement	The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for usewith ZrGEN Abutment are intended tobe sent to a MegaGen validated millingcenter for manufacture.	The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function inthe following situations and with theclinical protocols:-Delayed loading.-Immediate loading when good primarystability is achieved and with appropriateocclusal loading. Larger implants arededicated for the molar region.	The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous 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
ConnectionInterface	Internal Hex,Internal Non-Hex,Internal Conical Connection	Internal ConicalConnection	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)
SurfaceTreatment	Anodizing	Anodizing, Machined	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
RestorationType	Single & Multi	Single & Multi	Single & Multi
Principle ofOperation	This product is a pre-manufacturedprosthetic component directly orindirectly connected to the endosseousdental implant using its threaded partor screw for aid in prostheticrehabilitation.	This product is a pre-manufacturedprosthetic component directly orindirectly connected to the endosseousdental implant using its threaded part orscrew for aid in prosthetic rehabilitation.	This product is a pre-manufacturedprosthetic component directly orindirectly connected to the endosseousdental implant using its threaded part orscrew for aid in prosthetic rehabilitation.
CompatibleImplant System	XPEED AnyRidge Internal ImplantSystemAnyOne Internal Implant SystemBLUEDIAMOND IMPLANT System	BLUEDIAMOND IMPLANT System	XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND 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 forUse Statement	The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for usewith ZrGEN Abutment are intended to besent to a MegaGen validated millingcenter for manufacture.	The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function inthe following situations and with theclinical protocols:-Delayed loading.-Immediate loading when good primarystability is achieved and with appropriateocclusal loading. Larger implants arededicated for the molar region.	The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous 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, 4.5mm
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°
ConnectionInterface	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)
SurfaceTreatment	Anodizing	Machined	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
RestorationType	Single & Multi	Single & Multi	Single & Multi
Principle ofOperation	This product is a pre-manufacturedprosthetic component connected to theendosseous dental implant using thescrew and is intended for use as an aid inprosthetic rehabilitation.	This product is a pre-manufacturedprosthetic component directly orindirectly connected to the endosseousdental implant using its threaded part orscrew for aid in prosthetic rehabilitation.	This product is a pre-manufacturedprosthetic component connected to theendosseous dental implant using thescrew and is intended for use as an aid inprosthetic rehabilitation.
CompatibleImplantSystem	XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND IMPLANT System	BLUEDIAMOND IMPLANT System	XPEED AnyRidge Internal Implant SystemAnyOne internal Implant SystemBLUEDIAMOND 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

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 forUse Statement	The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for usewith ZrGEN Abutment are intended tobe sent to a MegaGen validated millingcenter for manufacture.	The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function inthe following situations and with theclinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Largerimplants are dedicated for the molarregion.	The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous 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
ConnectionInterface	Internal Hex,Internal Non-Hex,Internal Conical Connection	Internal ConicalConnection	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)
SurfaceTreatment	Anodizing, Machined	Anodizing, Machined	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
RestorationType	Single & Multi	Single & Multi	Single & Multi
Principle ofOperation	This product is a pre-manufacturedprosthetic component directly orindirectly connected to theendosseous dental implant using itsthreaded part or screw for aid inprosthetic rehabilitation.	This product is a pre-manufacturedprosthetic component directly orindirectly connected to theendosseous dental implant using itsthreaded part or screw for aid inprosthetic rehabilitation.	This product is a pre-manufacturedprosthetic component directly orindirectly connected to theendosseous dental implant using itsthreaded part or screw for aid inprosthetic rehabilitation.
CompatibleImplant System	XPEED AnyRidge Internal ImplantSystemAnyOne Internal Implant SystemBLUEDIAMOND IMPLANT System	BLUEDIAMOND IMPLANT System	XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND 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 forUse Statement	The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for usewith ZrGEN Abutment are intended to besent to a MegaGen validated millingcenter for manufacture.	The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function inthe following situations and with theclinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Largerimplants are dedicated for the molarregion.	The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous 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, 4.5mm
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°
ConnectionInterface	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)
SurfaceTreatment	Anodizing, Machined	Machined	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
RestorationType	Single & Multi	Single & Multi	Single & Multi
Principle ofOperation	This product is a pre-manufacturedprosthetic component connected to theendosseous dental implant using thescrew and is intended for use as an aid inprosthetic rehabilitation.	This product is a pre-manufacturedprosthetic component directly orindirectly connected to the endosseousdental implant using its threaded part orscrew for aid in prosthetic rehabilitation.	This product is a pre-manufacturedprosthetic component connected to theendosseous dental implant using thescrew and is intended for use as an aid inprosthetic rehabilitation.
CompatibleImplantSystem	XPEED AnyRidge Internal ImplantSystemAnyOne Internal Implant SystemBLUDIAMOND Implant System	BLUDIAMOND Implant System	Xpeed AnyRidge Internal ImplantSystemAnyOne Internal Implant SystemBLUDIAMOND 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 forUse Statement	The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for use withZrGEN Abutment are intended to be sentto a MegaGen validated milling center formanufacture.	The AnyOne Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than 6.0 mm) arededicated for immediate loadingwhen good primary stability is achievedand with appropriate occlusal loading.Larger implants are dedicated for themolar region and are indicated fordelayed loading.	The BLUEDIAMOND IMPLANT System isintended to be surgically placed in themaxillary or mandibular molarareas for the purpose ofprovidingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. These implantscan be used where smaller implantshave 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)
SurfaceTreatment	Machined, Anodizing	Machined	Machined, Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Abutment Screw is used forconnecting abutment for eachImplant System. The lower part hasmale screws depending on thefixture system to be connected.	Abutment screw is used for isused for connecting theAbutment to the fixture.	The Abutment Screw is used forconnecting Fixture to Abutment orAbutment to Cylinder.
CompatibleImplantSystem	XPEED AnyRidge Internal ImplantSystemAnyOne Internal Implant SystemBLUDIAMOND 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 forUse Statement	The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patients chewing function. Alldigitally designed abutments for usewith ZrGEN Abutment are intended to besent to a MegaGen validated millingcenter for manufacture.	The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals.	The AnyOne Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than 6.0 mm) arededicated for immediate loadingwhen good primary stability is achievedand with appropriate occlusal loading.Larger implants are dedicated for themolar region and are indicated fordelayed 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)
SurfaceTreatment	Machined	Machined	Machined
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	Cylinder Screw is used for connectingMulti-unit Abutment or Multi-unitAngled Abutment or AXA Abutment toHealing Cap, Temporary cylinder or EZPost Cylinder or CCM Cylinder.It is made of Ti-6AI-4V-ELI and offered inmachined surface. The Cylinder Screw issupplied non-sterile, to be sterilized bythe user according to the IFU andintended for single use.	Cylinder Screw is used forconnecting Multi-unit Abutment orMulti-unit Angled Abutment tohealing cap, Temporary Cylinder orCCM Cylinder.	Flat Cylinder Screw is used forconnecting Abutment to healing capor Cylinder.
CompatibleImplantSystem	XPEED AnyRidge Internal ImplantSystemAnyOne Internal Implant SystemBLUDIAMOND Implant System	XPEED AnyRidge Internal ImplantSystemBLUDIAMOND Implant SystemAnyOne 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 AbutmentScrew	Rosen Screw	Omniqrip Clinical Screw
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	BHI IMPLANTS LTD	Nobel Biocare
Indications forUse Statement	The MegaGen Dental ImplantAbutment is intended to besurgically placed in themaxillary or mandibular areasfor the purpose providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patientschewing function. All digitallydesigned abutments for usewith ZrGEN Abutment areintended to be sent to aMegaGen validated millingcenter for manufacture.	The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in themaxillary or mandibulararches for the purpose ofproviding prosthetic supportfor dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals.It is used to restore apatient's chewing function inthe following situations andwith the clinical protocols:-Delayed loading.-Immediate loading whengood primary stability isachieved and withappropriate occlusal loading.Larger implants arededicated for the molarregion.	The Bhdental Implant Systemis indicated for use in surgicaland restorative applicationsfor placement in the bone ofthe upper or lower jaw toprovide support for prostheticdevices, such as artificialteeth, in order to restore thepatient chewing function. TheBhdental Implant is alsoindicated for immediateloading when good primarystability is achieved and withappropriate occlusal loading.	The NobelProcera AngulatedScrew Channel AbutmentReplace are premanufacturedprosthetic componentsdirectly connected toendosseous dental implantsand are intended for use as anaid in prostheticrehabilitation.
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)
SurfaceTreatment	Machined	Machined	Machined, Anodizing	Machined, Anodizing
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Crown Screw is aprosthetic componentconnected to abutment andintended for use as an aid inprosthetic rehabilitaion. It ismade of Ti-6AI-4V-ELI andoffered in machined surface.The crown Screw is suppliednon-sterile, to be sterilized bythe user according to the IFUand intended for single use.	Multi-unit Abutment Screwis used for connecting Multi-unit Abutment or Multi-unitAngled Abutment to thefixture.	The Bhdental Implant Systemis indicated for use in surgicaland restorative applicationsfor placement in the bone ofthe upper or lower jaw toprovide support for prostheticdevices, such as artificialteeth, in order to restore thepatient chewing function.	The NobelProcera AngulatedScrew Channel AbutmentReplace are premanufacturedprosthetic componentsdirectly connected toendosseous dental implantsand are intended for use as anaid in prostheticrehabilitation.
CompatibleImplantSystem	XPEED AnyRidge InternalImplant SystemBLUDIAMOND ImplantSystemAnyOne Internal ImplantSystem	BLUDIAMOND ImplantSystem	N/A	N/A
Substantial Equivalence Discussion
1. SimilaritiesThe 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.

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Differences

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

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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.

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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.

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.)