Predicate Devices

Reference Devices

K210852, K200586, K203554, K182448, K150537, K123988, K110955, K192347, K210161, K220562, K122231, K230618

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a dental implant system and its components, focusing on materials, intended use, and performance testing. There is no mention of AI or ML technology in the description, intended use, or performance studies.

Therapeutic

No
The device, a dental implant system, aims to restore chewing function and support dental restorations, which are considered replacement or enhancement of body parts, not the treatment or prevention of disease, or affecting the structure or function of the body as a whole.

Diagnostic

No

Explanation: The device, the ARi ExCon Implant System, is intended for surgically placing dental implants to provide prosthetic support and restore chewing function. Its purpose is treatment and restoration, not diagnosis. The text only mentions material composition, placement, and performance testing, with no indication of diagnostic capabilities.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method," indicating it is a physical hardware device. The performance studies also focus on bench tests for fatigue and MR compatibility, which are relevant to hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The description clearly states that the ARi ExCon Implant System is a surgically placed device intended to provide prosthetic support for dental restorations. It is a physical implant placed in the body, not a test performed on a sample from the body.
Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes related to disease or condition identification.

Therefore, the ARi ExCon Implant System falls under the category of a medical device, specifically a dental implant system, rather than an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

Delayed loading
Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

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

DZE, NHA

Device Description

The ARi ExCon Implant System is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
The Abutments are prosthetic components directly or indirectly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation, allows single & multiple prosthetic restorations.

The ARi ExCon Implant System is consisted of the following components:

Fixture: ARi ExCon Implant (CP Ti Grade 4 of ASTM F67)
- Normal Thread: Ø 3.8 x 11.0, 13.0, 15.0 mm; Ø 4.3 x 11.0, 13.0, 15.0 mm; Ø 4.8 x 11.0, 13.0, 15.0 mm; Ø 5.3 x 11.0, 13.0, 15.0 mm
- Deep Thread: Ø 4.3 x 11.0, 13.0, 15.0 mm; Ø 4.8 x 11.0, 13.0, 15.0 mm; Ø 5.3 x 11.0, 13.0, 15.0 mm; Ø 5.8 x 11.0, 13.0, 15.0 mm
Prosthetics:
- Cover Screw (Ti-6Al-4V ELI of ASTM F136-13): Used to protect the inner structure of a fixture and exposed fixture platform. Dimensions: Ø 2.6 x 3.1 mm; Ø 3.2 x 3.1 mm; Ø 3.4 x 3.6, 4.1, 5.1 mm; Ø 4.0 x 3.6, 4.1, 5.1 mm. Angulation: Straight.
- Healing Abutment (Ti-6Al-4V ELI of ASTM F136-13): Helps to form suitable emergence profile during gingival healing. Dimensions: Ø 3.7 x 5.0-11.0 mm; Ø 4.2 x 5.0-11.0 mm; Ø 5.2 x 5.0-11.0 mm; Ø 6.2 x 5.0-11.0 mm. Angulation: Straight.
- Scan Healing Abutment (Ti-6Al-4V ELI of ASTM F136-13): Accessory for endosseous dental implants during healing to prepare gingival tissue for final abutment and restoration. Dimensions: Ø 4.2 x 4.5, 5.5, 7.5, 9.5 mm; Ø 4.7 x 4.5, 5.5, 7.5, 9.5 mm; Ø 5.7 x 4.5, 5.5, 7.5, 9.5 mm. Angulation: Straight.
- S.H.A Screw (Ti-6Al-4V ELI of ASTM F136-13): Secures the Scan Healing Abutment. Dimensions: Ø 2.0 x 5.33, 6.33, 8.33, 10.33 mm. Angulation: Straight.
- Temporary Abutment (Ti-6Al-4V ELI of ASTM F136-13): Provides support for provisional restoration. Dimensions: Ø 3.5, 4.0, 4.5 x 12.0 mm; Ø 3.5 x 10.0, 12.0, 14.0 mm; Ø 3.5, 4.0, 5.0, 6.0 x 10.0 mm. Angulation: Straight.
- EZ Post Abutment (Ti-6Al-4V ELI of ASTM F136-13): Support for cement and screw retained type final prosthesis. Dimensions: Ø 3.5-6.0 x 7.0-12.0 mm. Angulation: Straight.
- Angled Abutment (Ti-6Al-4V ELI of ASTM F136-13): Corrects prosthetic angulation of implant. Dimensions: Ø 4.0-6.0 x 9.0-12.0 mm. Angulation: 15°, 25°.
- Solid Abutment (Ti-6Al-4V ELI of ASTM F136-13): Support for final prosthesis (cement retained only). Dimensions: Ø 2.3 x 7.9, 9.9, 11.9 mm. Angulation: Straight.
- ZrGEN Abutment (Ti-6Al-4V ELI of ASTM F136-13): Two-piece abutment with titanium base cemented to zirconia top-half. Dimensions: Ø 4.0, 4.5 x 6.5-12.0 mm. Angulation: Straight.
- TiGEN Abutment (Ti-6Al-4V ELI of ASTM F136-13): Designed with the final prosthetic for intraoral structure. Dimensions: Ø 10.0, 12.0 x 26.0 mm. Angulation: Standard Type and Up to 30°.
- Abutment Screw (Ti-6Al-4V ELI of ASTM F136-13): Secures the abutment to the endosseous implant. Dimensions: Ø 2.5 x 5.1 mm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary or mandibular molar areas

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

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. The additional biocompatibility testing is not required on the ARi ExCon Implant system since ARi ExCon Implant system has same material composition, manufacturing process and patient contacting parts as the previously cleared device, XPEED AnyRidge Internal System (K122231), BLUEDIAMOND Implant System (K182448) and AnyRidge Internal Implant System (K110955).

Pyrogen and Endotoxin Test:
The subject device will not be labeled as "non-pyrogenic", and the endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP 39 .

Sterilization validation and Shelf life:
The ARi ExCon Implant, Cover Screw, Healing Abutment, Scan Healing Abutment and S.H.A Screw are supplied in sterile state. Sterilization validating testing has been performed in accordance with ISO 11137 to verify the sterility assurance level (10th). The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 years shelf life. The subject device is evaluated with previous device which was evaluated under the previous 510(k) submission, K122231. Also, the following guidance documents were referred to:

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

The Temporary Abutment, EZ Post Abutment, Angled Abutment, Solid Abutment, ZrGEN Abutmemt, TiGEN Abutment and Abutment Screw are supplied in non-sterile state. Sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 17665-1 and ISO 17665-2 to verify the sterility assurance level (10°). Validation Testing was conducted on a worst-case test article from our previously cleared device, K220562.

Modified Surface Treatment:
The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff".
The ARi ExCon Implant has same surface and manufacturing process with the previously our cleared devices of XPEED AnyRidge Internal System (K122231) for the surface treatment of S.L.A.
The Cover Screw, Healing Abutment, Scan Healing Abutment, S.H.A Screw, Temporary Abutment, EZ Post Abutment, Angled Abutment, Solid Abutment, TiGEN Abutment and ZrGEN Abutment have the same anodized surface treatment and manufacturing process as our previously cleared device, MiNi Internal Implant System (K150537), AnyOne External Implant System (K203554) and BLUEDIAMOND IMPLANT System (K182448).

Performance test:
The following bench tests have been performed in accordance with "ISO 14801" and "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.

Fatigue test

MR Compatibility:
The MR compatibility was performed to access the risk of exposing patients who have implantable medical devices according to FDA's guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".
An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for reference devices obtained the status of MR Conditional per K230618. Therefore, the subject devices are MR conditional devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per reference devices.

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

Not Found

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

K163634

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

K210852, K200586, K203554, K182448, K150537, K123988, K110955, K192347, K210161, K220562, K122231, K230618

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

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 7, 2023

MegaGen Implant Co., Ltd. Kyung-Hee Back Official Correspondent 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun Daegu, 42921 REPUBLIC OF KOREA

Re: K231967

Trade/Device Name: ARi ExCon Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 2, 2023 Received: November 2, 2023

Dear Kyung-Hee Back:

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

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

1

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

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

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

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

2

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

Sincerely,

Andrew I. Steen -S

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

Enclosure

3

Indications for Use

510(k) Number (if known) K231967

Device Name ARi ExCon Implant System

Indications for Use (Describe)

The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

Delayed loading
Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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V. 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR Part 807.92.

Date: December 6, 2023

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

Kyung-Hee Back MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: +82-53-222-3864 Fax: +82-53-289-3414 Email: ra9@imegagen.com

3. Device

. Trade Name:	ARi ExCon Implant System
---------------	--------------------------

Endosseous Dental Implant Common Name: .
- Implant, Endosseous, Root-Form
Primary Product Code: .

Classification Name:

DZE
. Secondary Product Code: NHA
Classification regulation: Class II, 21 CFR 872.3640 .

Predicate Device 4.

.

• Primary Predicate Device:

K163634 - External Hex Implants

•Reference Device:

K210852 Noris Medical Dental Implants System Cortical
K200586 Straumann TLX Implant System TLX S
K203554 AnyOne External Implant System
K182448 BLUEDIAMOND IMPLANT System
K150537 MiNi Internal Implant System
K123988 AnyOne Internal Implant System
K110955 AnyRidge Internal Implant System
K192347 ST Internal Implant System
K210161 AnyOne Onestage Implant System
K220562 TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment
K122231 XPEED AnyRidge Implant System
K230618 MegaGen Dental Implant Systems Portfolio MR Conditional

5

5. Description

. The ARi ExCon Implant is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
The Abutments are prosthetic components directly or indirectly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation, allows single & multiple prosthetic restorations.

Device		Content
1. Fixture	ARi ExCon Implant	Description	The ARi ExCon Implant is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
		Material	CP Ti Grade 4 of ASTM F67
		Dimension (Diameter & Total Length)	· Normal Thread
Ø 3.8 x 11.0, 13.0, 15.0 mm
Ø 4.3 x 11.0, 13.0, 15.0 mm
Ø 4.8 x 11.0, 13.0, 15.0 mm
Ø 5.3 x 11.0, 13.0, 15.0 mm
			· Deep Thread
Ø 4.3 x 11.0, 13.0, 15.0 mm
Ø 4.8 x 11.0, 13.0, 15.0 mm
Ø 5.3 x 11.0, 13.0, 15.0 mm
Ø 5.8 x 11.0, 13.0, 15.0 mm
2. Prosthetics	Cover Screw	Description	The Cover Screw is used in conjunction with fixture for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement.
		Material	Ti-6Al-4V ELI of ASTM F136-13
		Dimension (Diameter & Total Length)	Ø 2.6 x 3.1 mm
Ø 3.2 x 3.1 mm
Ø 3.4 x 3.6, 4.1, 5.1 mm
Ø 4.0 x 3.6, 4.1, 5.1 mm
		Angulation	Straight
	Healing Abutment	Description	The Healing Abutment is used in conjunction with fixture and helps to form suitable emergence profile during period of gingival healing.
		Material	Ti-6Al-4V ELI of ASTM F136-13
		Dimension (Diameter & Total Length)	Ø 3.7 x 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0 mm
Ø 4.2 x 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0 mm
Ø 5.2 x 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0 mm
Ø 6.2 x 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0 mm
		Angulation	Straight
	Scan Healing Abutment	Description	The Scan Healing Abutment is used for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
		Material	Ti-6Al-4V ELI of ASTM F136-13
		Dimension (Diameter & Total Length)	Ø 4.2 x 4.5, 5.5, 7.5, 9.5 mm
Ø 4.7 x 4.5, 5.5, 7.5, 9.5 mm
Ø 5.7 x 4.5, 5.5, 7.5, 9.5 mm
		Angulation	Straight
	S.H.A Screw	Description	At the top of the S.H.A Screw, an internal hex groove is processed so that it can be fastened with a driver, and at the bottom, a thread is formed so that it can be fastened with the internal female screw of the fixture.
		Material	Ti-6Al-4V ELI of ASTM F136-13
		Dimension (Diameter & Total Length)	Ø 2.0 x 5.33, 6.33, 8.33, 10.33 mm
		Angulation	Straight
	Temporary Abutment	Description	The Temporary Abutment is used in conjunction with fixture to provide support for provisional restoration.
		Material	Ti-6Al-4V ELI of ASTM F136-13
		Dimension (Diameter & Total Length)	Ø 3.5, 4.0, 4.5 x 12.0 mm
Ø 3.5 x 10.0, 12.0, 14.0 mm
Ø 3.5, 4.0, 5.0, 6.0 x 10.0 mm
		Angulation	Straight

י The ARi ExCon Implant System is consisted of the following components.

6

| | EZ Post
Abutment | Description |--|---------------------| | | | | (Diameter &
Total Length) Ø 4.0 x 7.0, 8.0, Ø 5.0 x 7.0, 8.0, Ø 6.0 x 7.0, 8.0, | | | | Angled
Abutment | Description | | | | (Diameter &
Total Length) Ø 5.0 x 9.0, 10.0, 11.0, 12.0 mm
Ø 6.0 x 9.0, 10.0, 11.0, 12.0 mm | | | | Solid
Abutment | Description | | | | (Diameter &
Total Length) | | | | ZrGEN
Abutment | Description | | | | (Diameter &
Total Length) Ø 4.5 x 6.5, 7.5, | | | | | | base | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | TiGEN
Abutment | Description | | Ø 10.0, 12.0 x 26.0 mm | | | | | (Diameter &
Total Length) &
Angulation | Standard
Type | | | | | | | | | | | | | | | | | | | | | | | Abutment
Screw | Description | | | (Diameter &
Total Length) | Ti-6Al-4V | The EZ Post Abutment is used in conjunction with fixture to provide support for cement and screw retained type final prosthesis. | | | | | | | |
-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------------|-------------------------------|--|--|--|-------------------------------------------|
| Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | | | | |
| Dimension
| Ø 3.5 x 7.0, 8.0, 9.0, 10.0, 11.0, 12.0 mm
9.0, 10.0, 11.0, 12.0 mm
9.0, 10.0, 11.0, 12.0 mm
9.0, 10.0, 11.0, 12.0 mm | | | | | | | |
| Angulation | Straight | | | | | | | |
| The Angled Abutment is used in conjunction with fixture and used for correcting the prosthetic angulation of implant. | | | | | | | |
| Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | | | | |
| Dimension
| Ø 4.0 x 9.0, 10.0, 11.0, 12.0 mm
| | | | | | | |
| Angulation | 15°, 25° | | | | | | | |
| The Solid Abutment is used in conjunction with fixture to provide support for final prosthesis, and used in cement retained type prosthesis only. | | | | | | | |
| Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | | | | |
| Dimension
| Ø 2.3 x 7.9, 9.9, 11.9 mm | | | | | | | |
| Angulation | Straight | | | | | | | |
| The ZrGEN Abutment is a two-piece abutment composed of the stock titanium base cemented together with the zirconia top-half to complete the final finished device. | | | | | | | |
| Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | | | | |
| Dimension
| Ø 4.0 x 6.5, 7.5, 8.0, 8.5, 9.0, 10.0, 11.0, 12.0 mm
8.0, 8.5, 9.0, 10.0, 11.0, 12.0 mm | | | | | | | |
| The allowable ranges of design parameters are follows: | | | | | | | |
| Titanium
| Minimum wall thickness (mm) | 0.5 | | | | | |
| | Minimum gingival collar (Ø) | 4.0 | | | | | |
| | Maximum gingival collar (Ø) | 4.5 | | | | | |
| | Minimum post height (mm) | 4.5 | | | | | |
| | Maximum post height (mm) | 8.0 | | | | | |
| The allowable ranges of design parameters after CAD/CAM patient-matching are follows: | | | | | | | |
| Zirconia top-half | Minimum wall thickness (mm) | 0.5 | | | | | |
| | 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 (mm) | 7 | | | | | |
| | Maximum post height (mm) | 15 | | | | | |
| Angulation | Straight | | | | | | | |
| The TiGEN Abutment is machined with the final prosthetic in accordance with the intraoral structure. | | | | | | | |
| Material | Ti-6Al-4V ELI of ASTM F136-13
| | | | | | | |
| The allowable ranges of design parameters after CAD/CAM patient-matching are follows: | | | | | | | |
| Dimension
| Minimum wall thickness (mm) | 0.05 | | | | | |
| | Maximum angulation (°) | 30 | | | | | |
| | Minimum gingival collar height (mm) | 4.00 | | | | | |
| | Maximum gingival collar height (mm) | 5.00 | | | | | |
| | Minimum gingival collar (Ø) | 4.00 | | | | | |
| | Maximum gingival collar (Ø) | 9.50, 11.50 | | | | | |
| | Minimum post height (mm) | 4.00 | | | | | |
| | Maximum post height (mm) | 6.00 | | | | | |
| The Abutment Screw is used for securing the abutment to the endosseous implant. | | | | | | | |
| | Material | Dimension
ELI of ASTM F136-13 | | | | $\text{\O} 2.5 \text{ x } 5.1 \text{ mm}$ |

7

6. Indication for use

The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

Delayed loading
Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

8

7. Basis for Substantial Equivalence

D1

The ARi ExCon Implant System are substantially equivalent to the predicate for use, technical characteristic and function. They are made of the same material and have similar design. The subject of the subject device slightly differ from the predicate device however it is very minor not affecting substantial equivalence.

Based on the technological characteristic comparison tables provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device.

TABLE 1 - TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

ARi ExCon Implant

Dimensions of the implants (Subject, Predicate and Reference devices)

(A) ARi ExCon Implant – Subject device (B) External Hex – Predical – Ref. 1 (D) Straumann TLX – Ref. 2 (E) MegaSen Implants – Ref. 4

Image /page/8/Figure/7 description: The image shows five different types of dental implants, labeled A through E. Each implant has a different design and is labeled with its name: A. ARi ExCon Implant, B. External Hex, C. Noris - Cortical, D. Straumann TLX, and E. MegaGen Implants (BLUEDIAMOND). Each implant has dimensions labeled as D1, L1, L2, L3-L2, and L2-L1.

| | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Reference Device 4 | Reference Device 5 | Manufacturer | MegaGen Implant Co.,
Ltd. | Southern Implants
(Pty) Ltd. | Noris Medical LTD | Institut Straumann AG | MegaGen Implant Co.,
Ltd. | MegaGen Implant Co.,
Ltd. | MegaGen Implant Co.,
Ltd. |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k | K231967 | K163634 | K210852 | K200586 | K203554 | K182448 | K122231 | Indication for
use | The ARi ExCon Implant
System is intended to
be surgically placed in
the maxillary or
mandibular molar
areas for the purpose
providing prosthetic
support for dental
restorations (Crown,
bridges, and
overdentures) in
partially or fully
edentulous
individuals. It is used
to restore a patient's
chewing function in
the following
situations and with the
clinical protocols:

Delayed loading
Immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading. | Southern Implants'
External Hex Implants
are intended for
surgical placement in
the upper or lower
jaw to provide a
means for prosthetic
attachment of
crowns, bridges or
overdentures utilizing
delayed or immediate
loading.
Southern Implants'
External Hex Implants
are intended for
immediate function
when good primary
stability with
appropriate occlusal
loading is achieved. | Noris Medical Dental
Implants System is
intended to replace
missing tooth/teeth in
either jaw for
supporting prosthetic
devices that may aid in
restoring the patient's
chewing function. The
procedure can be
accomplished in a one-
stage or two-stage
surgical operation. All
implants are
appropriate for
immediate loading
when good primary
stability is achieved and
with appropriate
occlusal loading. | Straumann TLX
Implants are suitable
for endosteal
implantation in the
upper and lower jaws
and for the functional
and esthetic oral
rehabilitation of
edentulous and
partially edentulous
patients. TLX Implants
can be placed with
immediate function on
single-tooth and multi-
unit restorations when
good primary stability
is achieved and with
appropriate occlusal
loading to restore
chewing function. The
prosthetic restorations
are connected to the
implants through the
corresponding
abutment
components. | The AnyOne External
Implant System is
intended to be
surgically placed in the
maxillary or
mandibular molar
areas for the purpose
providing prosthetic
support for dental
restorations (Crown,
bridges, and
overdentures) in
partially or fully
edentulous
individuals. It is used
to restore a patient's
chewing function.
Smaller implants (less
than 6.0 mm) are
dedicated for
immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading.
Larger implants are
dedicated for the
molar region and are
indicated for delayed
loading. | The BLUEDIAMOND
IMPLNAT System is
intended to be
surgically placed in the
maxillary or
mandibular molar
arches for the purpose
providing prosthetic
support for dental
restorations (Crown,
bridges, and
overdentures) in
partially or fully
edentulous individuals.
It is used to restore a
patient's chewing
function in chewing
function in the
following situations
and with the clinical
protocols:
Delayed loading
Immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading. Larger
implants are dedicated
for the molar region. | The XPEED AnyRidge
Internal Implant
System is intended to
be surgically placed in
the maxillary or
mandibular molar
areas for the purpose
providing prosthetic
support for dental
restorations (Crown,
bridges, and
overdentures) in
partially or fully
edentulous
individuals. It is used
to restore patients
chewing function.
Smaller implants (less
than 6.0 mm) are
dedicated for
immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading.
Larger implants are
dedicated for the
molar region and are
indicated for delayed
loading. |
| Device Name
(Compatible
Implant System) | ARi ExCon Implant
For ARi ExCon Implant
System | External Hex
Implants
For External Hex
Implants | Noris Medical Dental
Implants
For Noris Medical
Dental Implants System
Cortical | Straumann TLX
Straumann TLX Implant
System - TLX S | AnyOne External
Fixture
For AnyOne External
Implant System | BLUEDIAMOND
IMPLANT
For BLUEDIAMOND
IMPLANT System | XPEED AnyRidge
Internal Fixture
For XPEED AnyRidge
Internal Implant
System | Design | Image: MegaGen Implant | Image: Southern Implants | Image: Noris Medical LTD | Image: Institut Straumann AG | Image: MegaGen Implant | Image: MegaGen Implant | Image: MegaGen Implant |
| Widest Thread
Diameter (D1)
(Ø) & Total
Length (L3)
(mm) | · Normal Thread
Ø 3.8 × 11.0, 13.0, 15.0
Ø 4.3 × 11.0, 13.0, 15.0
Ø 4.8 × 11.0, 13.0, 15.0
Ø 5.3 × 11.0, 13.0, 15.0 | Ø3.25 × 8.5, 10.0, 11.5,
13.0, 15.0, 18.0 | Ø4.0 X 11.5, 13.0, 16.0,
18.0, 20.0
Ø5.0 X 11.5, 13.0, 16.0
Ø6.0 X 11.5, 13.0, 16.0 | Ø3.75 X 6.0, 8.0, 10.0,
12.0, 14.0, 16.0, 18.0
Ø4.0 X 6.0, 8.0, 10.0, 12.0,
14.0, 16.0, 18.0
Ø4.5 X 6.0, 8.0, 10.0, 12.0,
14.0, 16.0, 18.0
Ø5.0 X 6.0, 8.0, 10.0, 12.0,
14.0, 16.0, 18.0
Ø5.5 X 6.0, 8.0, 10.0, 12.0
Ø6.5 X 6.0, 8.0, 10.0, 12.0 | Ø3.9 x 7.0, 8.0, 9.5, 11.0,
12.5, 14.5
Ø4.3 x 7.0, 8.0, 9.5, 11.0,
12.5, 14.5
Ø4.8 x 7.0, 8.0, 9.5, 11.0,
12.5, 14.5
Ø5.3 x 7.0, 8.0, 9.5, 11.0,
| · Normal thread
Ø3.6 X 7.0, 7.7, 9.2, 10.7,
12.2, 14.2, 17.2
Ø4.0 X 7.0, 7.7, 9.2, 10.7,
12.2, 14.2, 17.2
Ø4.4 X 7.0, 7.7, 9.2, 10.7,
12.2, 14.2, 17.2
Ø4.7 X 7.0, 7.7, 9.2, 10.7,
12.2, 14.2, 17.2
Ø5.0 X 7.0, 7.7, 9.2, 10.7,
12.2, 14.2, 17.2 | · Normal thread
Ø4.0 X 7.7, 9.2, 10.7, 12.2,
14.2, 17.2
Ø4.4 X 7.7, 9.2, 10.7, 12.2,
14.2, 17.2
Ø4.9 X 7.7, 9.2, 10.7, 12.2,
14.2, 17.2
Ø5.4 X 7.7, 9.2, 10.7, 12.2,
14.2, 17.2
Ø5.9 X 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 | | | | | | | | |
| | Ø 4.0 × 6.0, 8.5, 10.0,
11.5, 13.0, 15.0, 18.0,
20.0 | | | | | | | | | | | | | | |
| | · Deep Thread
Ø 4.3 × 11.0, 13.0, 15.0
Ø 4.8 × 11.0, 13.0, 15.0
Ø 5.3 × 11.0, 13.0, 15.0 | Ø4.0 x 6.0, 8.5, 10.0,
11.5, 13.0, 15.0
Ø4.7x 10.0, 11.5, 13.0,
15.0, 18.0
Ø5.0 x 6.0, 8.5, 10.0,
11.5, 13.0, 15.0 | | | | | | | | | | | | | |

9

10

| | Ø 5.8 x 11.0, 13.0, 15.0 | 11.5, 13.0, 15.0, 18.0
Ø 5.7 x 10.0, 11.5, 13.0, 15.0, 18.0
Ø 6.0 x 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 | | | 12.5, 14.5
Ø6.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 | 12.2, 14.2, 17.2
• Deep thread
Ø4.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø4.4 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø4.8 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø5.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø5.5 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 | 14.2, 17.2
• Deep thread
Ø6.4 X 7.9, 9.4, 10.9, 12.4, 14.4
Ø6.9 X 7.9, 9.4, 10.9, 12.4, 14.4
Ø7.4 X 7.9, 9.4, 10.9, 12.4, 14.4
Ø7.9 X 7.9, 9.4, 10.9, 12.4, 14.4
Ø8.4 X 7.9, 9.4, 10.9, 12.4, 14.4 |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Threaded
Length
(mm) (L1) | For all diameters: 7.0, 9.0 | Unknown | For Ø4.0: 6.8, 8.0, 10.0, 11.0, 12.5
For Ø5.0: 6.8, 8.0, 10.0
For Ø6.0: 6.8, 8.0, 10.0 | For Ø3.75, 4.5: 7.0, 8.3, 10.3, 12.3, 14.0, 16.0
For Ø5.5: 7.0, 8.3, 10.3 | For all diameters: 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 | For all diameters: 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 | For all diameters: 7.7, 7.9, 9.2, 9.4, 10.7, 10.9, 12.2, 12.4, 14.2, 14.4, 17.2 |
| Implanted
Length (mm)
(L2)
(Length within the
bone) | For all diameters: 8.0, 9.0, 10.0, 11.0 | Unknown | For Ø4.0: 7.5, 9.0, 12.0, 14.0, 16.0
For Ø5.0: 7.5, 9.0, 12.0
For Ø6.0: 7.5, 9.0, 12.0 | For Ø3.75, 4.0, 4.5, 5.0:
6.0, 8.0, 10.0, 12.0, 14.0, 16.0, 18.0
For Ø5.5, 6.5: 6.0, 8.0, 10.0, 12.0 | For all diameters: 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 | For all diameters: 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 | For all diameters: 7.7, 7.9, 9.2, 9.4, 10.7, 10.9, 12.2, 12.4, 14.2, 14.4, 17.2 |
| Gingival (Cuff)
Height (mm)
(L3-L2) | 3.0, 4.0 | N/A | 4.0 | 3.3 | N/A | N/A | N/A |
| Thread to
Shoulder Height
(mm)
(L2-L1) | For L8.0: 1.0
For L9.0: 2.0
For L10.0: 1.0
For L11.0: 2.0 | N/A | For L7.5: 0.7
For L9.0: 1.0
For L12.0: 2.0
For L14.0: 3.0
For L16.0: 3.5 | For L8.0: 1.0
For L10.0, L12.0. L14.0: 1.7
For L16.0, L18.0: 2.0 | N/A | N/A | N/A |
| Implant to
Abutment
Connection | External Hex | External Hex | Internal Hex | TorcFit
(with conical fitting) | External Hex | Internal Octa | Internal Hex |
| Material | CP Ti Grade 4
(ASTM F67) | CP Ti Grade 4
(ASTM F67) | Titanium alloy | Titanium-13 Zirconium
alloy (Roxolid®) | CP Ti Grade 4
(ASTM F67) | CP Ti Grade 4
(ASTM F67) | CP Ti Grade 4
(ASTM F67) |
| Surface
Treatment | Sand-blasted, Large
grit, Acid-etched
(S.L.A)
Machined collar | Grit blasted
Machined collar | RBM | Hydrophilic SLActive® | Sand-blasted, Large
grit, Acid-etched
(S.L.A) | Sand-blasted, Large
grit, Acid-etched
(S.L.A) | Sand-blasted, Large
grit, Acid-etched
(S.L.A) |
| Sterilization | Sterile — irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation |
| Shelf Life | 5 Years | 5 Years | 5 Years | 5 Years | 5 Years | 5 Years | 5 Years |
| Feature | - Tapered body

0.8mm thread pitch | - Tapered body
Threaded | - Tapered body
Threaded | - Tapered body | - Tapered body
cutting edge with
self-tapping
0.8mm thread pitch | - Tapered body
cutting edge with
self-tapping
0.8mm thread pitch | - Tapered body
0.8 ~ 1.55mm thread
pitch |
| Substantial Equivalence Discussion | | | | | | | |
| 1. Similarities | | | | | | | |
| The subject device has the same characteristic for the followings compared to the Predicate device. | | | | | | | |

11

Indication for Use, Design, Implant to Abutment Connection, Material, Sterilization and Shelf-life. 2. Differences The subject device has the different characteristic for the followings compared to the Predicate device. - Widest Thread Diameter. Total Length The Widest Thread Diameter and Total Length of slightly different with predicate device is within any of subject device. It over not affect substantial equivalence. - Threaded Length The Threaded Length of the Predicate is unknown. But, all dimensions of subject devices (1, 2, 3, 4). It does not affect substantial equivalence. - Implanted Length The Inplanted Length of the Predicate is unknown. But, all dimensions of subject devices (1, 2, 3, 4, 5). It does not cause a natter in substantial equivalence. - Gingival (Cuff) Height The Girginal (Ciff) Height of the Predicted is unitim and subject device in evithin ange of Reference devices (1, 2). It does not cause a matter in substantial equivalence. - Thread to shoulder Height Thead to shoulder Height of the Predice device is unitim ange of subject device in within ange of Reference device 1. The variety of the size and e possible to perate more precise treatment to meet each patient's condition. It does not affect substantial equivalence. - Surface Treatment The subject device is treated with Sand-Arth All All While the predicate device is treated with Grit blasted, but has same Surface Treatment as reference device 3, 4 and 5. Subject device and predicate device has machined collar. - Feature The subject device has Tapered Body 0.8mm the the nas Tapered Boov and Threaded feature, but has same Feature as reference device 3, and 4. 3. Discussion The proposed Air Excon in all the tems in the comparison chart except the Widest Thread Dameter, Theaded Length, Incaded Length, Incaded Length, Incel (Coff) Height, Thread to shoulder Height, Surface Treature. But all dimensions of subject device lie within range of Predicate/Reference devices. The faige test was performed on worst as to confire of Collecte accoming on "Coss" (Joesal Cortrols Guilares) Cocument: Rott-form Endosseus Sental Inglants and Endosseus

Dental Includinent". The test result supports that is substantially equivalent to the predicate device and the differences are not affective the substantial equivalence.

On the basis of the discussion above, it is concluded that the substantially equivalent to the Predicate device.

12

Cover Screw

	Subject Device	Predicate Device	Reference Device 1	Reference Device 2
510k	K231967	K163634	K150537	K203554
Device Name
(Compatible
Implant System)	Cover Screw
For ARi ExCon Implant
System	Cover Screw
For External Hex Implants	Cover Screw
For MiNi Internal Implant
System	Cover Screw
For AnyOne External Implant
System
Manufacturer	MegaGen Implant Co., Ltd.	Southern Implants (Pty) Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication for
use	The ARi ExCon Implant
System is intended to be
surgically placed in the
maxillary or mandibular
molar areas for the purpose
providing prosthetic
support for dental
restorations (Crown,
bridges, and overdentures)
in partially or fully
edentulous individuals. It is
used to restore a patient's
chewing function in the
following situations and
with the clinical protocols:

Delayed loading
Immediate loading when
good primary stability is
achieved and with
appropriate occlusal
loading. | Southern Implants' External
Hex Implants are intended
for surgical placement in the
upper or lower jaw to
provide a means for
prosthetic attachment of
crowns, bridges or
overdentures utilizing
delayed or immediate
loading.
Southern Implants' External
Hex Implants are intended
for immediate function
when good primary stability
with appropriate occlusal
loading is achieved. | The MiNi Internal Implant
System is intended for two-
stage surgical procedures in
the following situations and
with the following clinical
protocols:
The intended use for the
3.0 mm diameter MiNi
implant is limited to the
replacement of maxillary
lateral incisors and
mandibular incisors. -
Immediate placement in
extraction sites and in
situations with a partially or
completely healed alveolar
ridge.- It is intended for
delayed loading. | The AnyOne External Implant
System is intended to be
surgically placed in the
maxillary or mandibular
molar areas for the purpose
providing prosthetic support
for dental restorations
(Crown, bridges, and
overdentures) in partially or
fully edentulous individuals.
It is used to restore a
patient's chewing function.
Smaller implants (less than
6.0 mm) are dedicated for
immediate loading when
good primary stability is
achieved and with
appropriate occlusal loading.
Larger implants are
dedicated for the molar
region and are indicated for
delayed loading. |
| Design | | | | |
| Diameter (Ø,
mm) | 2.6, 3.2, 3.4, 4.1 | 3.5, 5.0 | 2.6, 3.5 | 3.5, 4.1, 5.0 |
| Total Length
(mm) | 3.1, 3.6, 4.1, 5.1 | 4.35, 4.4 | 3.1 ~ 10.25 | 5.3, 6.2 |
| Connection
Interface | Conical Connection | Conical Connection | Conical Connection | Conical Connection |
| Material | Ti-6Al-4V ELI
(ASTM F136-13) | CPTi, Titanium alloy, Gold,
CoCr | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Anodizing | Machined, Anodizing | Anodizing, Machined | |
| Single Use | Yes | Yes | Yes
Yes | |
| Sterilization | Sterile - irradiation | Sterile - irradiation | Sterile — irradiation | Sterile — irradiation |
| | Substantial Equivalence Discussion | | | |
| 1.
Similarities | | | | |

The subject device has the same characteristic for the followings compared to the prior cleared Predicate device.

Indication for use, Design, Connection Interface, Surface Treatment, Single Use and Sterilization.

2. Difference

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

Diameter

The Diameter of subject device is slightly different with Predicate device, but the bounds of the cleared predicate and the reference devices. Also, it does not cause a matter in substantial equivalence since the size difference is very minor.

Total Length

The Total Length of subject device is slightly different with the prior cleared Predicate device, but all dimensions of subject device lie within range of the prior cleared Reference devices. Also, it does a matter in substantial equivalence since the size difference is very minor. -Material

The raw materials of the predicate device identified from K163634 are CPT, Titanium alloy, Gold, CoCr, which also includes the subject device's raw material (titanium alloy). Also, the raw materials of subject device are equivalent to the MegaGen's cleared reference devices.

Discussion

The proposed Cover Screw and Predicate device have common in all the terms in the Diameter, Total Length, Material.

However, these differences are not affect device's fundamental functions and safety. Therefore, it is substantial equivalent.

On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the Predicate device.

13

Healing Abutment

	Subject Device	Predicate Device	Reference Device
510k	K231967	K163634	K182448
Device Name
(Compatible
Implant System)	Healing Abutment
For ARi ExCon Implant System	Healing Abutment
For External Hex Implants	Healing Abutment
For BLUEDIAMOND IMPLANT System
Manufacturer	MegaGen Implant Co., Ltd.	Southern Implants (Pty) Ltd.	MegaGen Implant Co., Ltd.
Indication for use	The ARi ExCon Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas
for the purpose providing prosthetic
support for dental restorations
(Crown, bridges, and overdentures) in
partially or fully edentulous
individuals. It is used to restore a
patient's chewing function in the
following situations and with the
clinical protocols:

Delayed loading
Immediate loading when good
primary stability is achieved and with
appropriate occlusal loading. | Southern Implants' External Hex
Implants are intended for surgical
placement in the upper or lower jaw
to provide a means for prosthetic
attachment of crowns, bridges or
overdentures utilizing delayed or
immediate loading.
Southern Implants' External Hex
Implants are intended for immediate
function when good primary stability
with appropriate occlusal loading is
achieved. | The BLUEDIAMOND IMPLANT
System System is intended to be
surgically placed in the maxillary or
mandibular
arches for the purpose
of providing prosthetic support for
dental
restorations (Crown,
bridges, and overdentures) in
partially or fully edentulous
individuals. It is used to restore a
patient's chewing function in the
following situations and with the
clinical protocols:
-Delayed loading.
-Immediate loading when good
primary stability is achieved and
with
appropriate occlusal
loading. Larger
implants are
dedicated for the molar region. |
| Design | Image: Healing abutment | Image: Healing abutment | Image: Healing abutment |
| Diameter (Ø, mm) | 3.7, 4.2, 5.2, 6.2 | 4.5, 5.5, 6.5, 7.5 | 3.2, 4.2, 5.2, 6.2 |
| Post Height(mm) | 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5 | 2.2, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 | 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5 |
| Angulation | Straight | Straight | Straight |
| Connection
Interface | Conical Connection | Conical Connection | Conical Connection |
| Material | Ti-6Al-4V ELI
(ASTM F136-13) | CPTi, Titanium alloy, Gold,
CoCr | Ti-6Al-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Anodizing | Machined, Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation |
| Substantial Equivalence Discussion | | | |

1. Similarities

The subject device has the same characteristic for the followings compared to the prior cleared Predicate device.

Indication for use, Design, Angulation, Connection Interface, Surface Treatment, Single Use and Sterilization.

2. Difference

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

The Diameter of subject device is slightly different with the prior cleared the Predicate device. But, The diameter lies within range of the prior cleared Reference device.

Post Height
The Post Height of subject device is slightly different with the prior cleared the Predicate device. But all of post height are the same as the post height of the prior cleared reference devices.

-Material

The raw materials of the predicate device identified from K163634 are CPTi, Titanium alloy, Gold, CoCr, which also includes the subject device's raw material (titanium alloy). Also, the raw materials of subject device are equivalent to the MegaGen's cleared reference device.

3. Discussion

The proposed Healing Abutment and Predicate device have common in all the comparison chart except the Diameter, Post Height. Material.

However, these differences are not affect device's fundamental functions and safety. Therefore, it is substantial equivalent.

14

Scan Healing Abutment

	Subject Device	Reference Device
510k	K231967	K220562
Device Name
(Compatible
Implant System)	Scan Healing Abutment
For ARi ExCon Implant System	Scan Healing Abutment
For MegaGen's Implant systems
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication for use	The ARi ExCon Implant System is intended to be surgically
placed in the maxillary or mandibular molar areas for the
purpose providing prosthetic support for dental
restorations (Crown, bridges, and overdentures) in
partially or fully edentulous individuals. It is used to
restore a patient's chewing function in the following
situations and with the clinical protocols:

Delayed loading
Immediate loading when good primary stability is
achieved and with appropriate occlusal loading. | The TiGEN Abutment, ZrGEN Abutment and Scan
Healing Abutment are intended for use on
endosseous dental implants in the edentulous or
partially edentulous maxilla or mandible, as an aid
in prosthetic rehabilitation. |
| Design | Image: Design of ARi ExCon Implant System | Image: Design of MegaGen's Implant systems |
| Diameter (Ø, mm) | 4.2, 4.7, 5.7 | 4.2, 4.7, 5.7, 6.7 |
| Post Height (mm) | 3.0 | 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5 |
| Angulation | Straight | Straight |
| Connection
Interface | Conical Connection | Conical Connection |
| Material | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Anodizing and Machined | Anodizing |
| Single Use | Yes | Yes |
| Sterilization | Sterile - irradiation | Sterile - irradiation |
| Substantial Equivalence Discussion | | |

Similarities 1.

The subject device has the same characteristic for the followings compared to the prior cleared Reference device.

Indication for use, Design, Diameter, Angulation, Connection Interface, Material, Surface Treatment, Single Use and Sterilization. 2. Difference

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

Post Height

The Post Height of subject device is slightly different with the prior cleared the Reference device. But, The within range of the prior cleared Reference device.

3. Discussion

The proposed Scan Healing Abutment and Reference device have common the comparison chart except the Post Height. However, these differences are not affect device's fundamental functions and safety. Therefore, it is substantial equivalent.

15

S.H.A Screw

	Subject Device	Reference Device
510k	K231967	K220562
Device Name
(Compatible
Implant System)	S.H.A Screw
For ARi ExCon Implant System	S.H.A Screw
For MegaGen's Implant systems
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication for use	The ARi ExCon Implant System is intended to be surgically
placed in the maxillary or mandibular molar areas for the
purpose providing prosthetic support for dental
restorations (Crown, bridges, and overdentures) in
partially or fully edentulous individuals. It is used to
restore a patient's chewing function in the following
situations and with the clinical protocols:

Delayed loading
Immediate loading when good primary stability is
achieved and with appropriate occlusal loading. | The TiGEN Abutment, ZrGEN Abutment and Scan
Healing Abutment are intended for use on
endosseous dental implants in the edentulous or
partially edentulous maxilla or mandible, as an aid
in prosthetic rehabilitation. |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameter (Ø, mm) | 2.0 | 1.95, 2.0, 2.1 |
| Total Length
(mm) | 5.33, 6.33, 8.33, 10.33 | 9.4, 9.8, 10.4, 10.6, 10.8, 11.6, 12.4, 12.8, 13.6 |
| Material | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Anodizing and Machined | Anodizing and Machined |
| Single Use | Yes | Yes |
| Sterilization | Sterile - irradiation | Sterile - irradiation |
| Substantial Equivalence Discussion | | |
| 1.
Similarities | | |

The subject device has the same characteristic for the followings compared to the prior cleared Reference device.

Indication for use, Design, Diameter, Material, Surface Treatment, Single Use and Sterilization.

2. Difference

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

- Total Length

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

3. Discussion

The proposed S.H.A Screw and Reference device have common in all the terms in the comparison chart except the Total Length. However, this difference is not affect device's fundamental functions and safety. Therefore, it is substantial equivalent.

16

Temporary Abutment

	Subject Device	Predicate Device	Reference Device 1	Reference Device 2
510k	K231967	K163634	K203554	K123988
Device Name
(Compatible
Implant System)	Temporary Abutment
For ARi ExCon Implant
System	Titanium Abutment
For External Hex Implants	Temporary Abutment
For AnyOne External
Implant System	Temporary Abutment
For AnyOne Internal
Implant System
Manufacturer	MegaGen Implant Co., Ltd.	Southern Implants (Pty) Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication for use	The ARi ExCon Implant
System is intended to be
surgically placed in the
maxillary or mandibular
molar areas for the
purpose providing
prosthetic support for
dental restorations
(Crown, bridges, and
overdentures) in partially
or fully edentulous
individuals. It is used to
restore a patient's chewing
function in the following
situations and with the
clinical protocols:

Delayed loading
Immediate loading when
good primary stability is
achieved and with
appropriate occlusal
loading. | Southern Implants' External
Hex Implants are intended
for surgical placement in the
upper or lower jaw to
provide a means for
prosthetic attachment of
crowns, bridges or
overdentures utilizing
delayed or immediate
loading.
Southern Implants' External
Hex Implants are intended
for immediate function when
good primary stability with
appropriate occlusal loading
is achieved. | The AnyOne External
Implant System is intended
to be surgically placed in
the maxillary or
mandibular molar areas for
the purpose providing
prosthetic support for
dental restorations
(Crown, bridges, and
overdentures) in partially
or fully edentulous
individuals. It is used to
restore a patient's chewing
function. Smaller implants
(less than 6.0 mm) are
dedicated for immediate
loading when good primary
stability is achieved and
with appropriate occlusal
loading. Larger implants
are dedicated for the
molar region and are
indicated for delayed
loading. | The AnyOne™ Internal
Implant System is intended
to be surgically placed in the
maxillary or mandibular
molar areas for the purpose
providing prosthetic support
for dental restorations
(Crown, bridges, and
overdentures) in partially or
fully edentulous individuals.
It is used to restore a
patient's chewing function.
Smaller implants (less than
$Ø$ 6.0 mm) are dedicated for
immediate loading when
good primary stability is
achieved and with
appropriate occlusal
loading. Larger implants are
dedicated for the molar
region and are indicated for
delayed loading. |
| Design | Image: design | Image: design | Image: design | Image: design |
| Diameter ( $Ø$ , mm) | 3.5, 4.0, 4.5, 5.0, 6.0 | 5.0, 6.0 | 3.9, 4.5, 4.8, 5.5 | 4.5 |
| Post Height(mm) | 8.0, 10.0, 12.0 | Unknown | 7.5, 10.0 | 9.5 |
| Gingival
Height(mm) | 2.0 | 1.0, 5.0 | 1.3, 2.8 | 1.3 |
| Angulation | Straight | Straight | Straight | Straight |
| Connection
Interface | External Hex | External Hex | External Hex,
External Non-Hex | Internal Hex |
| Material | Ti-6Al-4V ELI
(ASTM F136-13),
POM
(Delrin 100P NC010) | CPTi, Titanium alloy, Gold,
CoCr | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13),
POM
(Delrin 100P NC010) |
| Surface
Treatment | Machined, Anodizing | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Sterile - irradiation | Non-sterile | Non-sterile |
| Substantial Equivalence Discussion | | | | |

1. Similarities

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

Indication for use, Design, Angulation, Connection Interface and Single Use.

2. Difference

The subject device has the different characteristic for the followings compared to the Predicate Device. - Diameter

Most diameters are within within range of predicate device. The rest of diameter(3.5mm) is slightly smaller than the diameter of reference devices. It does not cause a matter in substantial equivalence size differences are very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.

Post Height

The Post Height of the predicate device are unknown. The post height of slightly different with reference devices. But, these size differences are very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.

Gingival Height

The Gingival Height of subject device is slightly different with predicate device, but all of gingival height lie within range of predicate device. - Material

The raw materials of the predicate device identified from K163634 are CPTi, Titanium alloy, Gold, CoCr, which also includes the subject

17

device's raw material (titanium alloy). Also, the raw materials of subject device are equivalent to the MegaGen's cleared reference device 2. - 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. - Sterilization

Sterilization of subject device is non-sterile. Predicate device is identified product from K163634. Although the subject device is a non-sterile product, there are other proposed products (cover screw, healing abutment) that use the same sterilization method as the predicated device.

3.

The proposed Temporary Abutment and Predicate device have common in all the terms in the Diameter, Post Height, Gingival Height, Material and Surface Treatment, Sterilization. These differences are not affect device's functions and safety. Also, the fatigue testing is not considered since the proposed device is straight type and temporarily used.

On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the Reference devices.

18

EZ Post Abutment

	Subject Device	Predicate Device	Reference Device		Subject Device	Predicate Device	Reference Device 1	Reference Device 2
510k	K231967	K163634	K203554	510k	K231967	K163634	K203554	K110955
Device Name
(Compatible
Implant System)	EZ Post Abutment
For ARi ExCon Implant System	Anatomic Abutment
For External Hex Implants	EZ Post Abutment
For AnyOne External Implant System	Device Name
(Compatible
Implant System)	Angled Abutment
For ARi ExCon Implant
System	Cosmetic Abutment
For External Hex Implants	Angled Abutment
For AnyOne External
Implant System	Angled Abutment
For AnyRidge Internal
Implant System
Manufacturer	MegaGen Implant Co., Ltd.	Southern Implants (Pty) Ltd.	MegaGen Implant Co., Ltd.	Manufacturer	MegaGen Implant Co., Ltd.	Southern Implants (Pty)
Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication for use	The ARi ExCon Implant System is
intended to be surgically placed in
the maxillary or mandibular molar
areas for the purpose providing
prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing
function in the following situations
and with the clinical protocols:

Delayed loading
Immediate loading when good
primary stability is achieved and
with appropriate occlusal loading. | Southern Implants' External Hex
Implants are intended for surgical
placement in the upper or lower
jaw to provide a means for
prosthetic attachment of crowns,
bridges or overdentures utilizing
delayed or immediate loading.
Southern Implants' External Hex
Implants are intended for
immediate function when good
primary stability with appropriate
occlusal loading is achieved. | The AnyOne External Implant
System is intended to be
surgically placed in the maxillary or
mandibular molar areas for the
purpose providing prosthetic support
for dental restorations (Crown,
bridges, and overdentures) in
partially or fully edentulous
individuals. It is used to restore a
patient's chewing function. Smaller
implants (less than 6.0 mm) are
dedicated for immediate loading
when good primary stability is
achieved and with appropriate
occlusal loading. Larger implants
are dedicated for the molar region and
are indicated for delayed
loading. | Indication for
use | The ARi ExCon Implant
System is intended to be
surgically placed in the
maxillary or mandibular
molar areas for the
purpose providing
prosthetic support for
dental restorations
(Crown, bridges, and
overdentures) in partially
or fully edentulous
individuals. It is used to
restore a patient's chewing
function in the following
situations and with the
clinical protocols:
Delayed loading
Immediate loading when
good primary stability is
achieved and with
appropriate occlusal
loading. | Southern Implants'
External Hex Implants are
intended for surgical
placement in the upper or
lower jaw to provide a
means for prosthetic
attachment of crowns,
bridges or overdentures
utilizing delayed or
immediate loading.
Southern Implants'
External Hex Implants are
intended for immediate
function when good
primary stability with
appropriate occlusal
loading is achieved. | The AnyOne External
Implant System is intended
to be surgically placed in
the maxillary or
mandibular molar areas for
the purpose providing
prosthetic support for
dental restorations
(Crown, bridges, and
overdentures) in partially
or fully edentulous
individuals. It is used to
restore a patient's chewing
function. Smaller implants
(less than 6.0 mm) are
dedicated for immediate
loading when good
primary stability is
achieved and with
appropriate occlusal
loading. Larger implants
are dedicated for the
molar region and are
indicated for delayed
loading. | The AnyRidge Internal
Implant System is intended
to be surgically placed in
the maxillary or
mandibular molar areas for
the purpose providing
prosthetic support for
dental restorations (Crown,
bridges, and overdentures)
in partially or fully
edentulous individuals. It is
used to restore a patients
chewing function. Smaller
implants (less than 6.0
mm) are dedicated for
immediate loading when
good primary stability is
achieved and with
appropriate occlusal
loading. Larger implants
are dedicated for the
molar region and are
indicated for delayed
loading. | |
| Design | | | | Design | Image: angled abutment | Image: cosmetic abutment | Image: angled abutment | Image: angled abutment | |
| Diameter ( $Ø$ , mm) | 3.5, 4.0, 5.0, 6.0 | 3.4, 3.43, 4.05, 5.0, 6.0 | 4.0, 5.0, 6.0 | Diameter (Ø,
mm) | 4.0, 5.0, 6.0 | 3.43, 4.05, 5.0, 6.0 | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0, 7.0 | |
| Post Height(mm) | 5.0, 6.0, 7.0, 8.0, 9.0, 10.0 | Unknown | 8.0 | Post
Height(mm) | 7.0 | Unknown | 7.0 | 7.0 | |
| Gingival
Height(mm) | 2.0 | 2.0, 3.5, 5.0 | 1.0, 2.0, 3.0, 4.0 | Gingival
Height(mm) | 2.0, 3.0, 4.0, 5.0 | 2.0, 2.6, 2.9, 3.0, 3.5 | 2.0, 4.0 | 1.8, 2.8, 3.8, 4.8 | |
| Angulation | Straight | Straight | Straight | Angulation | 15°, 25° | 12°, 24° | 15°, 25° | 15°, 25° | |
| Connection
Interface | External Hex | External Hex | External Hex, External Non-Hex | Connection
Interface | External Hex | External Hex | External Hex,
External Non-Hex | Hex, Non-Hex | |
| Material | Ti-6Al-4V ELI
(ASTM F136-13) | CPTi, Titanium alloy, Gold, CoCr | Ti-6Al-4V ELI
(ASTM F136-13) | Material | Ti-6Al-4V ELI
(ASTM F136-13) | CPTi, Titanium alloy, Gold,
CoCr | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) | |
| Surface
Treatment | Machined, Anodizing | Machined | Anodizing | Surface
Treatment | Machined, Anodizing | Machined | Anodizing | Anodizing, Machined | |
| Single Use | Yes | Yes | Yes | Single Use | Yes | Yes | Yes | Yes | |
| Sterilization | Non-sterile | Sterile - irradiation | Non-sterile | Sterilization | Non-sterile | Sterile - irradiation | Non-sterile | Non-sterile | |
| | Substantial Equivalence Discussion | | | | Substantial Equivalence Discussion | | | | |

1. Similarities

The subject device has the same characteristic for the followings compared to the prior cleared Predicate device.

Indication for use, Design, Gingival Height, Angulation, Connection Interface and Single Use.

2. Difference

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

The Diameter of the subject device is slightly different with the Predicate device. But all of Diameter lie within range of Predicate device. - Post Height

The Post Height of the predicate device is unknown. 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. -Material

The raw materials of the predicate device identified from K163634 are CPT, Titanium alloy, Gold, CoCr, which also includes the subject device's raw material (titanium alloy). Also, the raw materials of subject device are equivalent to the MegaGen's cleared reference device.

Surface Treatment

The subject device is treated with machined and anodizing while the predicate device is treated with machined, a surface treatment method, is the same as the MegaGen's cleared reference device. - Sterilization

Sterilization of subject device is non-sterile. The predicate device is identified as sterilized product from K163634. Although the subject device is a non-sterile product, there are other products (cover screw, healing abutment) that use the same sterilization method as the predicated device and are equivalent to the MegaGen's cleared reference device.

Discussion

The proposed EZ Post Abutment and Predicate device have common in all the comparison chart except the Diameter, Post Height, Material and Surface Treatment, Sterilization. These differences are not affect device's fundamental functions and safety. Also, the proposed product is a straight type abutment, the fatigue test was performed as a representative of the worst case model with angle. On the basis of the discussion above, it is concluded that the substantially equivalent to the Reference devices.

19

Angled Abutment

1. Similarities

The subject device has the same characteristic for the followings compared to the prior cleared Predicate Device..

Indication for use, Design, Connection Interface and Single Use.

2. Difference

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

Diameter
The Diameter of the subject device is slightly different with the prior cleared Predicate device lie within range of the predicate device.
Post Height The Post Height of the predicate device is unknown. But the subject device is same as the prior cleared reference

device.

Gingival Height

The Gingival Height of the subject device is slightly different with the predicate device. Most dimensions are within the range of the predicate device, but some are slightly longer. However, its dimensions are almost same as MegaGen's cleared reference device 2. lt does not cause a matter in substantial equivalence size differences are very minor, and the variety of the size can be

20

possible to operate more precise treatment to meet each patient's condition.

Angulation

The angulation of the subject device is slightly different with the prior cleared Predicate device, but the subject device is same as the prior cleared reference devices.

Material
The raw materials of the predicate device identified from K163634 are CPTi, Titanium alloy, Gold, CoCr, which also includes the target device's raw material (titanium alloy). Also, the raw materials of subject device are equivalent to the MegaGen's cleared reference devices.
Surface Treatment
The subject device is treated with machined and anodizing while the predicate device is treated with machined, a surface treatment method, is the same as the MegaGen's cleared reference device. -Sterilization

Sterilization of subject device is non-sterile. The Predicate device is identified as sterilized product from K163634. Although the subject device is a non-sterile product, there are other products (cover screw, healing abutment) that use the same sterilization method as the predicated device and are equivalent to the MegaGen's cleared reference device.

3. Discussion

The proposed Angled Abutment and Predicate device have common in all the comparison chart except the Diameter, Post Height, Gingival Height, Angulation, Material, Surface Treatment, Sterilization. The differences are explained not affecting on the substantial equivalence, but the fatigue test was performed on the subject device to confirm the substantial equivalence. The subject device with angled(Angled Abutment) has selected as the representative specimen in this submission according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant Abutment'. The test result supports that the subject device is substantially equivalent to the Predicate device and differences are not affecting the substantial equivalence.

21

Solid Abutment

	Subject Device	Reference Device 1	Reference Device 2
510k	K231967	K150537	K192347
Device Name
(Compatible
Implant System)	Solid Abutment
For ARi ExCon Implant System	Solid Abutment
For MiNi Internal Implant System	Solid Abutment
For ST Internal Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication for
use	The ARi ExCon Implant System is
intended to be surgically placed in
the maxillary or mandibular molar
areas for the purpose providing
prosthetic support for dental
restorations (Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function
in the following situations and with
the clinical protocols:

Delayed loading
Immediate loading when good
primary stability is achieved and with
appropriate occlusal loading. | The MiNi Internal Implant System is
intended for two-stage surgical
procedures in the following
situations and with the following
clinical protocols:
The intended use for the 3.0 mm
diameter MiNi implant is limited to
the replacement of maxillary lateral
incisors and mandibular incisors. -
Immediate placement in extraction
sites and in situations with a partially
or completely healed alveolar ridge .-
It is intended for delayed loading. | The ST Internal Implant System is
intended to be surgically placed in
the maxillary or mandibular arches
for the purpose providing prosthetic
support for dental restorations
(Crown, bridges, and overdentures)
in partially or fully edentulous
individuals. It is used to restore a
patient's chewing function. Smaller
implants (less than 6.0 mm) are
dedicated for immediate loading
when good primary stability is
achieved and with appropriate
occlusal loading. Larger implants are
dedicated for the molar region and
are indicated for delayed loading. |
| Design | Image: Design of ARi ExCon Implant System | Image: Design of MiNi Internal Implant System | Image: Design of ST Internal Implant System |
| Diameter (Ø,
mm) | 2.3 | 3.0, 3.5 | 4.0, 4.6, 5.0, 6.0, 7.0 |
| Post
Height(mm) | 5.0, 7.0, 9.0 | 5.5, 7.0, 9.0 | 4.0, 5.5, 7.0 |
| Material | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Anodizing | Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Substantial Equivalence Discussion | | | |

1. Similarities

The subject device has the same characteristic for the followings compared to the prior cleared Reference devices.

Indication for use, Design, Material, Surface Treatment, Single Use and Sterilization.

2. Difference

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

- Diameter

The Diameter of subject device is slightly smaller than the prior cleared reference devices.

Post Height
The Post Height of subject device is slightly different with the reference device, but the post height iies within range of cleared reference device 1,2. Also, it does not cause a matter in substantial equivalence since the size difference is very minor.

3. Discussion

The proposed solid Abutment and reference devices have common in Indication for use, Design, Material, Single Use, Sterilization except the Diameter and Post Height. Although there are some differences are not affect device's fundamental functions and safety. Also, the proposed product is a straight type abutment, the fatigue test was performed as a representative of the worst case model with angle. On the discussion above, it is concluded that the subject device is substantially equivalent to the Reference devices.

22

ZrGEN Abutment

	Subject Device	Reference Device
510k	K231967	K220562
Device Name
(Compatible
Implant System)	ZrGEN Abutment
For ARi ExCon Implant System	ZrGEN Abutment
For MegaGen's Implant systems
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication for use	The ARi ExCon Implant System is intended to be surgically
placed in the maxillary or mandibular molar areas for the
purpose providing prosthetic support for dental
restorations (Crown, bridges, and overdentures) in
partially or fully edentulous individuals. It is used to
restore a patient's chewing function in chewing function
in the following situations and with the clinical protocols:

Delayed loading
Immediate loading when good primary stability is
achieved and with appropriate occlusal loading.
For TiGEN Abutment and ZrGEN Abutment, all digitally
designed abutments for use with TiGEN Abutment and
ZrGEN Abutment are intended to be sent to a MegaGen-
validated milling center for manufacture. | The TiGEN Abutment, ZrGEN Abutment and Scan
Healing Abutment are intended for use on
endosseous dental implants in the edentulous or
partially edentulous maxilla or mandible, as an aid
in prosthetic rehabilitation.
For TiGEN Abutment and ZrGEN Abutment, all digitally
designed abutments for use with TiGEN Abutment and
ZrGEN Abutment are intended to be sent to a
MegaGen-validated milling center for manufacture. |
| Design | Image: ZrGEN Abutment | Image: ZrGEN Abutment |
| Diameter (Ø, mm) | 4.0, 4.5 | 3.1, 3.9, 4.0, 4.3, 4.4, 4.5, 5.0, 5.5, 6.0, 6.5 |
| Total Length
(mm) | 6.5, 7.5, 8.0, 8.5, 9.0, 10.0, 11.0, 12.0 | 5.10, 5.50, 5.80, 7.50, 7.70, 7.90, 8.00, 8.15, 8.20, 8.35,
8.40, 8.60, 8.70, 8.85, 8.90, 9.00, 9.05, 9.20, 9.40, 9.50,
9.65, 9.70, 9.85, 9.90, 10.10, 10.35, 10.40, 10.55, 11.15,
11.35, 11.55, 11.65, 12.05, 12.55, 13.05, 13.15, 13.55,
14.05, 14.55, 15.05, 15.55, 16.55 |
| Top-half Material | Zirconia ISO13356 | Zirconia ISO13356 |
| Range of Top-half
Design Parameter
(mm) | Diameter: Min 8.0
Gingival Collar Height: Min 2.0
Post Height: Min 7.0 | Diameter: Min 8.0
Gingival Collar Height: Min 2.0
Post Height: Min 7.0 |
| Angulation | Straight | Straight |
| Connection
Interface | Conical Connection | Conical Connection |
| Material | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Machined | Machined |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| Substantial Equivalence Discussion | | |

Similarities 1.

The subject device has the same characteristic for the followings compared to the prior cleared Reference device.

Indication for use, Design, Diameter, Top-half Design Parameter, Angulation, Connection Interface, Material, Surface Treatment, Single Use and Sterilization.

Difference

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

Total Length

The Total Length of subject device is slightly different with the prior cleared the Reference device. But, The Total Length in swithin range of the prior cleared Reference device.

Discussion

The proposed ZrGEN Abutment and Reference device have common in all the terms in the comparison chart except the Total Length. However, this difference is not affect device's fundamental functions and safety. Therefore, it is substantial equivalent.

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TiGEN Abutment

	Subject Device	Reference Device
510k	K231967	K220562
Device Name
(Compatible
Implant System)	TiGEN Abutment
For ARi ExCon Implant System	TiGEN Abutment
For MegaGen's Implant systems
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication for use	The ARi ExCon Implant System is intended to be surgically
placed in the maxillary or mandibular molar areas for the
purpose providing prosthetic support for dental
restorations (Crown, bridges, and overdentures) in
partially or fully edentulous individuals. It is used to
restore a patient's chewing function in chewing function
in the following situations and with the clinical protocols:

Delayed loading
Immediate loading when good primary stability is
achieved and with appropriate occlusal loading.

For TiGEN Abutment and ZrGEN Abutment, all digitally
designed abutments for use with TiGEN Abutment and
ZrGEN Abutment are intended to be sent to a MegaGen-
validated milling center for manufacture. | The TiGEN Abutment, ZrGEN Abutment and Scan
Healing Abutment are intended for use on
endosseous dental implants in the edentulous or
partially edentulous maxilla or mandible, as an aid
in prosthetic rehabilitation.

Similarities 1.

The subject device has the same characteristic for the followings compared to the prior cleared Reference device.

Indication for use, Design, Diameter, Angulation Interface, Material, Surface Treatment, Single Use and Sterilization. 2. Difference & Discussion

The proposed TiGEN Abutment and Reference device have common in all the terms in the comparison, and can be considered practically equivalent, except for the difference in the configuration of the implant used together.

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Abutment Screw

	Subject Device	Reference Device 1	Reference Device 2
510k	K231967	K203554	K210161
Device Name
(Compatible
Implant
System)	Abutment Screw
For ARi ExCon Implant System	Abutment Screw
For AnyOne External Implant System	Abutment Screw
For AnyOne Onestage Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication for
use	The ARi ExCon Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas
for the purpose providing prosthetic
support for dental restorations
(Crown, bridges, and overdentures) in
partially or fully edentulous
individuals. It is used to restore a
patient's chewing function in the
following situations and with the
clinical protocols:

Delayed loading
Immediate loading when good
primary stability is achieved and with
appropriate occlusal loading. | The AnyOne External Implant System is
intended to be surgically placed in the
maxillary or mandibular molar areas
for the purpose providing prosthetic
support for dental restorations
(Crown, bridges, and overdentures)
in partially or fully edentulous
individuals. It is used to restore a
patient's chewing function. Smaller
implants (less than 6.0 mm) are
dedicated for immediate loading when
good primary stability is achieved and with
appropriate occlusal loading.
Larger implants are dedicated for the
molar region and are indicated for
delayed loading. | The AnyOne Onestage Implant
System is intended to be
surgically placed in the maxillary or
mandibular arches for the purpose of
providing prosthetic support for
dental restorations (Crown,
bridges, and overdentures) in
partially or fully edentulous
individuals. It is used to restore a
patient's chewing function in the
following situations and with the
clinical protocols:
-Delayed loading.
-Immediate loading when good
primary stability is achieved and with
appropriate occlusal loading.
Larger implants are dedicated for the molar
region. |
| Design | Image: Abutment Screw | Image: Abutment Screw | Image: Abutment Screw |
| Diameter (Ø,
mm) | 2.5 | 2.45, 2.5 | 2.5, 2.6 |
| Total Length
(mm) | 5.1 | 4.8, 7.5 | 4.85, 5.5 |
| Material | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Substantial Equivalence Discussion | | | |

1. Similarities

The subject device has the same characteristic for the followings compared to the prior cleared reference device 1.

Indication for use, Design, Diameter, Material, Surface Treatment, Single Use and Sterilization.

2. Difference

The subject device has the different characteristic for the followings compared to the reference device 1.

Total Length

The Total Length of subject device is slightly different with the prior cleared reference device 1. The Total Length of subject device is slightly different with Reference device 1, but the dimension of subject device lies within range Reference devices. Also, it does not cause a matter in substantial equivalence since the size difference is very minor.

3. Discussion

The proposed Abutment Screw and reference device 1 have common in all the items except the Total Length difference is explained not affecting on the substantial equivalence.

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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. The additional biocompatibility testing is not required on the ARi ExCon Implant system since ARi ExCon Implant system has same material composition, manufacturing process and patient contacting parts as the previously cleared device, XPEED AnyRidge Internal System (K122231), BLUEDIAMOND Implant System (K182448) and AnyRidge Internal Implant System (K110955).

Pyrogen and Endotoxin Test

The subject device will not be labeled as "non-pyrogenic", and the endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP 39 .

Sterilization validation and Shelf life

The ARi ExCon Implant, Cover Screw, Healing Abutment, Scan Healing Abutment and S.H.A Screw are supplied in sterile state. Sterilization validating testing has been performed in accordance with ISO 11137 to verify the sterility assurance level (10th). The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 years shelf life. The subject device is evaluated with previous device which was evaluated under the previous 510(k) submission, K122231. Also, the following guidance documents were referred to:

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

The Temporary Abutment, EZ Post Abutment, Angled Abutment, Solid Abutment, ZrGEN Abutmemt, TiGEN Abutment and Abutment Screw are supplied in non-sterile state. Sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 17665-1 and ISO 17665-2 to verify the sterility assurance level (10°). Validation Testing was conducted on a worst-case test article from our previously cleared device, K220562.

Modified Surface Treatment

The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff".

The ARi ExCon Implant has same surface and manufacturing process with the previously our cleared devices of XPEED AnyRidge Internal System (K122231) for the surface treatment of S.L.A.

The Cover Screw, Healing Abutment, Scan Healing Abutment, S.H.A Screw, Temporary Abutment, EZ Post Abutment, Angled Abutment, Solid Abutment, TiGEN Abutment and ZrGEN Abutment have the same anodized surface treatment and manufacturing process as our previously cleared device, MiNi Internal Implant System (K150537), AnyOne External Implant System (K203554) and BLUEDIAMOND IMPLANT System (K182448).

Performance test

The following bench tests have been performed in accordance with "ISO 14801" and "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.

26

Fatigue test

MR Compatibility

The MR compatibility was performed to access the risk of exposing patients who have implantable medical devices according to FDA's guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".

An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for reference devices obtained the status of MR Conditional per K230618. Therefore, the subject devices are MR conditional devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per reference devices.

9. Conclusion

Based on the information provided in this premarket notification, We, MegaGen Implant Co., Ltd. conclude that the ARi ExCon Implant System is substantially equivalent to the predicate device as here.