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.

Device 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.

AI/ML Overview

The provided text is an FDA 510(k) premarket notification summary for the "ARi ExCon Implant System." It details various components of the dental implant system (implants, cover screws, healing abutments, etc.) and compares them to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance study, such as an MRMC study. The "Performance test" section on page 25-26 only mentions fatigue testing according to ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of subject devices (implant components), and that test results met pre-set criteria. This is a mechanical performance test, not a clinical or human-reader study.

Therefore, I cannot fulfill the request for information regarding:

A table of acceptance criteria and reported device performance (in the context of AI/human performance).
Sample size for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method.
MRMC comparative effectiveness study results or effect size.
Standalone (algorithm-only) performance.
Type of ground truth used (clinical/AI performance).
Training set sample size.
How training set ground truth was established.

The document primarily focuses on demonstrating substantial equivalence of the dental implant components through material comparisons and mechanical bench testing to predicate and reference devices, not on the performance of a medical AI device or human-in-the-loop performance with AI assistance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). 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.

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

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

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

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

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

Sincerely,

Andrew I. Steen -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K231967

Device Name ARi ExCon Implant System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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

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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 ThreadØ 3.8 x 11.0, 13.0, 15.0 mmØ 4.3 x 11.0, 13.0, 15.0 mmØ 4.8 x 11.0, 13.0, 15.0 mmØ 5.3 x 11.0, 13.0, 15.0 mm
			· Deep ThreadØ 4.3 x 11.0, 13.0, 15.0 mmØ 4.8 x 11.0, 13.0, 15.0 mmØ 5.3 x 11.0, 13.0, 15.0 mmØ 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 mmØ 3.2 x 3.1 mmØ 3.4 x 3.6, 4.1, 5.1 mmØ 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 mmØ 4.2 x 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0 mmØ 5.2 x 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0 mmØ 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 mmØ 4.7 x 4.5, 5.5, 7.5, 9.5 mmØ 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 mmØ 3.5 x 10.0, 12.0, 14.0 mmØ 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.

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EZ PostAbutment	Description	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(Diameter &Total Length)	Ø 3.5 x 7.0, 8.0, 9.0, 10.0, 11.0, 12.0 mmØ 4.0 x 7.0, 8.0, 9.0, 10.0, 11.0, 12.0 mmØ 5.0 x 7.0, 8.0, 9.0, 10.0, 11.0, 12.0 mmØ 6.0 x 7.0, 8.0, 9.0, 10.0, 11.0, 12.0 mm
	Angulation	Straight
AngledAbutment	Description	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(Diameter &Total Length)	Ø 4.0 x 9.0, 10.0, 11.0, 12.0 mmØ 5.0 x 9.0, 10.0, 11.0, 12.0 mmØ 6.0 x 9.0, 10.0, 11.0, 12.0 mm
	Angulation	15°, 25°
SolidAbutment	Description	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(Diameter &Total Length)	Ø 2.3 x 7.9, 9.9, 11.9 mm
	Angulation	Straight
ZrGENAbutment	Description	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(Diameter &Total Length)	Ø 4.0 x 6.5, 7.5, 8.0, 8.5, 9.0, 10.0, 11.0, 12.0 mmØ 4.5 x 6.5, 7.5, 8.0, 8.5, 9.0, 10.0, 11.0, 12.0 mm
		The allowable ranges of design parameters are follows:
		Titaniumbase	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
TiGENAbutment	Description	The TiGEN Abutment is machined with the final prosthetic in accordance with the intraoral structure.
	Material	Ti-6Al-4V ELI of ASTM F136-13Ø 10.0, 12.0 x 26.0 mm
		The allowable ranges of design parameters after CAD/CAM patient-matching are follows:
	Dimension(Diameter &Total Length) &Angulation	StandardType	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
AbutmentScrew	Description	The Abutment Screw is used for securing the abutment to the endosseous implant.
			Material	Dimension(Diameter &Total Length)	Ti-6Al-4V ELI of ASTM F136-13	$\text{\O} 2.5 \text{ x } 5.1 \text{ mm}$

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6. Indication for use

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.

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7. Basis for Substantial Equivalence

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 foruse	The ARi ExCon ImplantSystem is intended tobe surgically placed inthe maxillary ormandibular molarareas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulousindividuals. It is usedto restore a patient'schewing function inthe followingsituations and with theclinical protocols:- Delayed loading- Immediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.	Southern Implants'External Hex Implantsare intended forsurgical placement inthe upper or lowerjaw to provide ameans for prostheticattachment ofcrowns, bridges oroverdentures utilizingdelayed or immediateloading.Southern Implants'External Hex Implantsare intended forimmediate functionwhen good primarystability withappropriate occlusalloading is achieved.	Noris Medical DentalImplants System isintended to replacemissing tooth/teeth ineither jaw forsupporting prostheticdevices that may aid inrestoring the patient'schewing function. Theprocedure can beaccomplished in a one-stage or two-stagesurgical operation. Allimplants areappropriate forimmediate loadingwhen good primarystability is achieved andwith appropriateocclusal loading.	Straumann TLXImplants are suitablefor endostealimplantation in theupper and lower jawsand for the functionaland esthetic oralrehabilitation ofedentulous andpartially edentulouspatients. TLX Implantscan be placed withimmediate function onsingle-tooth and multi-unit restorations whengood primary stabilityis achieved and withappropriate occlusalloading to restorechewing function. Theprosthetic restorationsare connected to theimplants through thecorrespondingabutmentcomponents.	The AnyOne ExternalImplant System isintended to besurgically placed in themaxillary ormandibular molarareas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulousindividuals. It is usedto restore a patient'schewing function.Smaller implants (lessthan 6.0 mm) arededicated forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.Larger implants arededicated for themolar region and areindicated for delayedloading.	The BLUEDIAMONDIMPLNAT System isintended to besurgically placed in themaxillary ormandibular molararches for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulous individuals.It is used to restore apatient's chewingfunction in chewingfunction in thefollowing situationsand with the clinicalprotocols:- Delayed loading- Immediate loadingwhen good primarystability is achievedand with appropriateocclusal loading. Largerimplants are dedicatedfor the molar region.	The XPEED AnyRidgeInternal ImplantSystem is intended tobe surgically placed inthe maxillary ormandibular molarareas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulousindividuals. It is usedto restore patientschewing function.Smaller implants (lessthan 6.0 mm) arededicated forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.Larger implants arededicated for themolar region and areindicated for delayedloading.
Device Name(CompatibleImplant System)	ARi ExCon ImplantFor ARi ExCon ImplantSystem	External HexImplantsFor External HexImplants	Noris Medical DentalImplantsFor Noris MedicalDental Implants System- Cortical	Straumann TLXStraumann TLX ImplantSystem - TLX S	AnyOne ExternalFixtureFor AnyOne ExternalImplant System	BLUEDIAMONDIMPLANTFor BLUEDIAMONDIMPLANT System	XPEED AnyRidgeInternal FixtureFor XPEED AnyRidgeInternal ImplantSystem	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 ThreadDiameter (D1)(Ø) & TotalLength (L3)(mm)	· Normal ThreadØ 3.8 × 11.0, 13.0, 15.0Ø 4.3 × 11.0, 13.0, 15.0Ø 4.8 × 11.0, 13.0, 15.0Ø 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, 20.0Ø5.0 X 11.5, 13.0, 16.0Ø6.0 X 11.5, 13.0, 16.0	Ø3.75 X 6.0, 8.0, 10.0,12.0, 14.0, 16.0, 18.0Ø4.0 X 6.0, 8.0, 10.0, 12.0,14.0, 16.0, 18.0Ø4.5 X 6.0, 8.0, 10.0, 12.0,14.0, 16.0, 18.0Ø5.0 X 6.0, 8.0, 10.0, 12.0,14.0, 16.0, 18.0Ø5.5 X 6.0, 8.0, 10.0, 12.0Ø6.5 X 6.0, 8.0, 10.0, 12.0	Ø3.9 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5Ø4.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5Ø4.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5Ø5.3 x 7.0, 8.0, 9.5, 11.0,	· Normal threadØ3.6 X 7.0, 7.7, 9.2, 10.7,12.2, 14.2, 17.2Ø4.0 X 7.0, 7.7, 9.2, 10.7,12.2, 14.2, 17.2Ø4.4 X 7.0, 7.7, 9.2, 10.7,12.2, 14.2, 17.2Ø4.7 X 7.0, 7.7, 9.2, 10.7,12.2, 14.2, 17.2Ø5.0 X 7.0, 7.7, 9.2, 10.7,12.2, 14.2, 17.2	· Normal threadØ4.0 X 7.7, 9.2, 10.7, 12.2,14.2, 17.2Ø4.4 X 7.7, 9.2, 10.7, 12.2,14.2, 17.2Ø4.9 X 7.7, 9.2, 10.7, 12.2,14.2, 17.2Ø5.4 X 7.7, 9.2, 10.7, 12.2,14.2, 17.2Ø5.9 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 ThreadØ 4.3 × 11.0, 13.0, 15.0Ø 4.8 × 11.0, 13.0, 15.0Ø 5.3 × 11.0, 13.0, 15.0	Ø4.0 x 6.0, 8.5, 10.0,11.5, 13.0, 15.0Ø4.7x 10.0, 11.5, 13.0,15.0, 18.0Ø5.0 x 6.0, 8.5, 10.0,11.5, 13.0, 15.0

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{10}------------------------------------------------

	Ø 5.8 x 11.0, 13.0, 15.0	11.5, 13.0, 15.0, 18.0Ø 5.7 x 10.0, 11.5, 13.0, 15.0, 18.0Ø 6.0 x 7.0, 8.5, 10.0, 11.5, 13.0, 15.0			12.5, 14.5Ø6.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5	12.2, 14.2, 17.2• Deep threadØ4.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2Ø4.4 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2Ø4.8 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2Ø5.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2Ø5.5 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2	14.2, 17.2• Deep threadØ6.4 X 7.9, 9.4, 10.9, 12.4, 14.4Ø6.9 X 7.9, 9.4, 10.9, 12.4, 14.4Ø7.4 X 7.9, 9.4, 10.9, 12.4, 14.4Ø7.9 X 7.9, 9.4, 10.9, 12.4, 14.4Ø8.4 X 7.9, 9.4, 10.9, 12.4, 14.4
ThreadedLength(mm) (L1)	For all diameters: 7.0, 9.0	Unknown	For Ø4.0: 6.8, 8.0, 10.0, 11.0, 12.5For Ø5.0: 6.8, 8.0, 10.0For Ø6.0: 6.8, 8.0, 10.0	For Ø3.75, 4.5: 7.0, 8.3, 10.3, 12.3, 14.0, 16.0For 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
ImplantedLength (mm)(L2)(Length within thebone)	For all diameters: 8.0, 9.0, 10.0, 11.0	Unknown	For Ø4.0: 7.5, 9.0, 12.0, 14.0, 16.0For Ø5.0: 7.5, 9.0, 12.0For 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, 18.0For 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 toShoulder Height(mm)(L2-L1)	For L8.0: 1.0For L9.0: 2.0For L10.0: 1.0For L11.0: 2.0	N/A	For L7.5: 0.7For L9.0: 1.0For L12.0: 2.0For L14.0: 3.0For L16.0: 3.5	For L8.0: 1.0For L10.0, L12.0. L14.0: 1.7For L16.0, L18.0: 2.0	N/A	N/A	N/A
Implant toAbutmentConnection	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 Zirconiumalloy (Roxolid®)	CP Ti Grade 4(ASTM F67)	CP Ti Grade 4(ASTM F67)	CP Ti Grade 4(ASTM F67)
SurfaceTreatment	Sand-blasted, Largegrit, Acid-etched(S.L.A)Machined collar	Grit blastedMachined collar	RBM	Hydrophilic SLActive®	Sand-blasted, Largegrit, Acid-etched(S.L.A)	Sand-blasted, Largegrit, Acid-etched(S.L.A)	Sand-blasted, Largegrit, 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 withself-tapping- 0.8mm thread pitch	- Tapered body- cutting edge withself-tapping- 0.8mm thread pitch	- Tapered body- 0.8 ~ 1.55mm threadpitch
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(CompatibleImplant System)	Cover ScrewFor ARi ExCon ImplantSystem	Cover ScrewFor External Hex Implants	Cover ScrewFor MiNi Internal ImplantSystem	Cover ScrewFor AnyOne External ImplantSystem
Manufacturer	MegaGen Implant Co., Ltd.	Southern Implants (Pty) Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication foruse	The ARi ExCon ImplantSystem is intended to besurgically placed in themaxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function in thefollowing situations andwith the clinical protocols:- Delayed loading- Immediate loading whengood primary stability isachieved and withappropriate occlusalloading.	Southern Implants' ExternalHex Implants are intendedfor surgical placement in theupper or lower jaw toprovide a means forprosthetic attachment ofcrowns, bridges oroverdentures utilizingdelayed or immediateloading.Southern Implants' ExternalHex Implants are intendedfor immediate functionwhen good primary stabilitywith appropriate occlusalloading is achieved.	The MiNi Internal ImplantSystem is intended for two-stage surgical procedures inthe following situations andwith the following clinicalprotocols:- The intended use for the3.0 mm diameter MiNiimplant is limited to thereplacement of maxillarylateral incisors andmandibular incisors. -Immediate placement inextraction sites and insituations with a partially orcompletely healed alveolarridge.- It is intended fordelayed loading.	The AnyOne External ImplantSystem is intended to besurgically placed in themaxillary or mandibularmolar areas for the purposeproviding prosthetic supportfor dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals.It is used to restore apatient's chewing function.Smaller implants (less than6.0 mm) are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusal loading.Larger implants arededicated for the molarregion and are indicated fordelayed loading.
Design
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
ConnectionInterface	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)
SurfaceTreatment	Anodizing	Machined, Anodizing	Anodizing, Machined
Single Use	Yes	Yes	YesYes
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(CompatibleImplant System)	Healing AbutmentFor ARi ExCon Implant System	Healing AbutmentFor External Hex Implants	Healing AbutmentFor BLUEDIAMOND IMPLANT System
Manufacturer	MegaGen Implant Co., Ltd.	Southern Implants (Pty) Ltd.	MegaGen Implant Co., Ltd.
Indication for use	The ARi ExCon Implant System isintended to be surgically placed in themaxillary or mandibular molar areasfor the purpose providing prostheticsupport for dental restorations(Crown, bridges, and overdentures) inpartially or fully edentulousindividuals. It is used to restore apatient's chewing function in thefollowing situations and with theclinical protocols:- Delayed loading- Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading.	Southern Implants' External HexImplants are intended for surgicalplacement in the upper or lower jawto provide a means for prostheticattachment of crowns, bridges oroverdentures utilizing delayed orimmediate loading.Southern Implants' External HexImplants are intended for immediatefunction when good primary stabilitywith appropriate occlusal loading isachieved.	The BLUEDIAMOND IMPLANTSystem System is intended to besurgically placed in the maxillary ormandibulararches for the purposeof providing prosthetic support fordentalrestorations (Crown,bridges, and overdentures) inpartially or fully edentulousindividuals. It is used to restore apatient's chewing function in thefollowing situations and with theclinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwithappropriate occlusalloading. Largerimplants arededicated 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
ConnectionInterface	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)
SurfaceTreatment	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(CompatibleImplant System)	Scan Healing AbutmentFor ARi ExCon Implant System	Scan Healing AbutmentFor 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 surgicallyplaced in the maxillary or mandibular molar areas for thepurpose providing prosthetic support for dentalrestorations (Crown, bridges, and overdentures) inpartially or fully edentulous individuals. It is used torestore a patient's chewing function in the followingsituations and with the clinical protocols:- Delayed loading- Immediate loading when good primary stability isachieved and with appropriate occlusal loading.	The TiGEN Abutment, ZrGEN Abutment and ScanHealing Abutment are intended for use onendosseous dental implants in the edentulous orpartially edentulous maxilla or mandible, as an aidin 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
ConnectionInterface	Conical Connection	Conical Connection
Material	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)
SurfaceTreatment	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(CompatibleImplant System)	S.H.A ScrewFor ARi ExCon Implant System	S.H.A ScrewFor 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 surgicallyplaced in the maxillary or mandibular molar areas for thepurpose providing prosthetic support for dentalrestorations (Crown, bridges, and overdentures) inpartially or fully edentulous individuals. It is used torestore a patient's chewing function in the followingsituations and with the clinical protocols:- Delayed loading- Immediate loading when good primary stability isachieved and with appropriate occlusal loading.	The TiGEN Abutment, ZrGEN Abutment and ScanHealing Abutment are intended for use onendosseous dental implants in the edentulous orpartially edentulous maxilla or mandible, as an aidin 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)
SurfaceTreatment	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(CompatibleImplant System)	Temporary AbutmentFor ARi ExCon ImplantSystem	Titanium AbutmentFor External Hex Implants	Temporary AbutmentFor AnyOne ExternalImplant System	Temporary AbutmentFor AnyOne InternalImplant System
Manufacturer	MegaGen Implant Co., Ltd.	Southern Implants (Pty) Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication for use	The ARi ExCon ImplantSystem is intended to besurgically placed in themaxillary or mandibularmolar areas for thepurpose providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) in partiallyor fully edentulousindividuals. It is used torestore a patient's chewingfunction in the followingsituations and with theclinical protocols:- Delayed loading- Immediate loading whengood primary stability isachieved and withappropriate occlusalloading.	Southern Implants' ExternalHex Implants are intendedfor surgical placement in theupper or lower jaw toprovide a means forprosthetic attachment ofcrowns, bridges oroverdentures utilizingdelayed or immediateloading.Southern Implants' ExternalHex Implants are intendedfor immediate function whengood primary stability withappropriate occlusal loadingis achieved.	The AnyOne ExternalImplant System is intendedto be surgically placed inthe maxillary ormandibular molar areas forthe purpose providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) in partiallyor fully edentulousindividuals. It is used torestore a patient's chewingfunction. Smaller implants(less than 6.0 mm) arededicated for immediateloading when good primarystability is achieved andwith appropriate occlusalloading. Larger implantsare dedicated for themolar region and areindicated for delayedloading.	The AnyOne™ InternalImplant System is intendedto be surgically placed in themaxillary or mandibularmolar areas for the purposeproviding prosthetic supportfor dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals.It is used to restore apatient's chewing function.Smaller implants (less than$Ø$ 6.0 mm) are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implants arededicated for the molarregion and are indicated fordelayed 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
GingivalHeight(mm)	2.0	1.0, 5.0	1.3, 2.8	1.3
Angulation	Straight	Straight	Straight	Straight
ConnectionInterface	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)
SurfaceTreatment	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(CompatibleImplant System)	EZ Post AbutmentFor ARi ExCon Implant System	Anatomic AbutmentFor External Hex Implants	EZ Post AbutmentFor AnyOne External Implant System	Device Name(CompatibleImplant System)	Angled AbutmentFor ARi ExCon ImplantSystem	Cosmetic AbutmentFor External Hex Implants	Angled AbutmentFor AnyOne ExternalImplant System	Angled AbutmentFor AnyRidge InternalImplant 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 isintended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewingfunction in the following situationsand with the clinical protocols:- Delayed loading- Immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.	Southern Implants' External HexImplants are intended for surgicalplacement in the upper or lowerjaw to provide a means forprosthetic attachment of crowns,bridges or overdentures utilizingdelayed or immediate loading.Southern Implants' External HexImplants are intended forimmediate function when goodprimary stability with appropriateocclusal loading is achieved.	The AnyOne External ImplantSystem is intended to besurgically placed in the maxillary ormandibular molar areas for thepurpose providing prosthetic supportfor dental restorations (Crown,bridges, and overdentures) inpartially or fully edentulousindividuals. It is used to restore apatient's chewing function. Smallerimplants (less than 6.0 mm) arededicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implantsare dedicated for the molar region andare indicated for delayedloading.	Indication foruse	The ARi ExCon ImplantSystem is intended to besurgically placed in themaxillary or mandibularmolar areas for thepurpose providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) in partiallyor fully edentulousindividuals. It is used torestore a patient's chewingfunction in the followingsituations and with theclinical protocols:- Delayed loading- Immediate loading whengood primary stability isachieved and withappropriate occlusalloading.	Southern Implants'External Hex Implants areintended for surgicalplacement in the upper orlower jaw to provide ameans for prostheticattachment of crowns,bridges or overdenturesutilizing delayed orimmediate loading.Southern Implants'External Hex Implants areintended for immediatefunction when goodprimary stability withappropriate occlusalloading is achieved.	The AnyOne ExternalImplant System is intendedto be surgically placed inthe maxillary ormandibular molar areas forthe purpose providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) in partiallyor fully edentulousindividuals. It is used torestore a patient's chewingfunction. Smaller implants(less than 6.0 mm) arededicated for immediateloading when goodprimary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for themolar region and areindicated for delayedloading.	The AnyRidge InternalImplant System is intendedto be surgically placed inthe maxillary ormandibular molar areas forthe purpose providingprosthetic support fordental restorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patientschewing function. Smallerimplants (less than 6.0mm) are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for themolar region and areindicated for delayedloading.
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	PostHeight(mm)	7.0	Unknown	7.0	7.0
GingivalHeight(mm)	2.0	2.0, 3.5, 5.0	1.0, 2.0, 3.0, 4.0	GingivalHeight(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°
ConnectionInterface	External Hex	External Hex	External Hex, External Non-Hex	ConnectionInterface	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)
SurfaceTreatment	Machined, Anodizing	Machined	Anodizing	SurfaceTreatment	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

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.

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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.

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Solid Abutment

	Subject Device	Reference Device 1	Reference Device 2
510k	K231967	K150537	K192347
Device Name(CompatibleImplant System)	Solid AbutmentFor ARi ExCon Implant System	Solid AbutmentFor MiNi Internal Implant System	Solid AbutmentFor ST Internal Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication foruse	The ARi ExCon Implant System isintended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing functionin the following situations and withthe clinical protocols:- Delayed loading- Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading.	The MiNi Internal Implant System isintended for two-stage surgicalprocedures in the followingsituations and with the followingclinical protocols:- The intended use for the 3.0 mmdiameter MiNi implant is limited tothe replacement of maxillary lateralincisors and mandibular incisors. -Immediate placement in extractionsites and in situations with a partiallyor completely healed alveolar ridge .-It is intended for delayed loading.	The ST Internal Implant System isintended to be surgically placed inthe maxillary or mandibular archesfor the purpose providing prostheticsupport for dental restorations(Crown, bridges, and overdentures)in partially or fully edentulousindividuals. It is used to restore apatient's chewing function. Smallerimplants (less than 6.0 mm) arededicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare 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
PostHeight(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)
SurfaceTreatment	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.

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ZrGEN Abutment

	Subject Device	Reference Device
510k	K231967	K220562
Device Name(CompatibleImplant System)	ZrGEN AbutmentFor ARi ExCon Implant System	ZrGEN AbutmentFor 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 surgicallyplaced in the maxillary or mandibular molar areas for thepurpose providing prosthetic support for dentalrestorations (Crown, bridges, and overdentures) inpartially or fully edentulous individuals. It is used torestore a patient's chewing function in chewing functionin the following situations and with the clinical protocols:- Delayed loading- Immediate loading when good primary stability isachieved and with appropriate occlusal loading.For TiGEN Abutment and ZrGEN Abutment, all digitallydesigned abutments for use with TiGEN Abutment andZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.	The TiGEN Abutment, ZrGEN Abutment and ScanHealing Abutment are intended for use onendosseous dental implants in the edentulous orpartially edentulous maxilla or mandible, as an aidin prosthetic rehabilitation.For TiGEN Abutment and ZrGEN Abutment, all digitallydesigned abutments for use with TiGEN Abutment andZrGEN Abutment are intended to be sent to aMegaGen-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-halfDesign Parameter(mm)	Diameter: Min 8.0Gingival Collar Height: Min 2.0Post Height: Min 7.0	Diameter: Min 8.0Gingival Collar Height: Min 2.0Post Height: Min 7.0
Angulation	Straight	Straight
ConnectionInterface	Conical Connection	Conical Connection
Material	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)
SurfaceTreatment	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(CompatibleImplant System)	TiGEN AbutmentFor ARi ExCon Implant System	TiGEN AbutmentFor 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 surgicallyplaced in the maxillary or mandibular molar areas for thepurpose providing prosthetic support for dentalrestorations (Crown, bridges, and overdentures) inpartially or fully edentulous individuals. It is used torestore a patient's chewing function in chewing functionin the following situations and with the clinical protocols:- Delayed loading- Immediate loading when good primary stability isachieved and with appropriate occlusal loading.For TiGEN Abutment and ZrGEN Abutment, all digitallydesigned abutments for use with TiGEN Abutment andZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.	The TiGEN Abutment, ZrGEN Abutment and ScanHealing Abutment are intended for use onendosseous dental implants in the edentulous orpartially edentulous maxilla or mandible, as an aidin prosthetic rehabilitation.For TiGEN Abutment and ZrGEN Abutment, all digitallydesigned abutments for use with TiGEN Abutment andZrGEN Abutment are intended to be sent to aMegaGen-validated milling center for manufacture.
Design	Image: Subject Device Design	Image: Reference Device Design
Diameter (Ø, mm)	10.0, 12.0	10.0, 12.0
Total Length(mm)	26.00	26.00, 28.00, 28.40, 28.60, 28.70, 28.90, 29.05, 30.55
Angulation	Up to 30°	Up to 30°
ConnectionInterface	Conical Connection	Conical Connection
Material	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)
SurfaceTreatment	Anodizing and Machined	Anodizing
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, 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(CompatibleImplantSystem)	Abutment ScrewFor ARi ExCon Implant System	Abutment ScrewFor AnyOne External Implant System	Abutment ScrewFor AnyOne Onestage Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indication foruse	The ARi ExCon Implant System isintended to be surgically placed in themaxillary or mandibular molar areasfor the purpose providing prostheticsupport for dental restorations(Crown, bridges, and overdentures) inpartially or fully edentulousindividuals. It is used to restore apatient's chewing function in thefollowing situations and with theclinical protocols:- Delayed loading- Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading.	The AnyOne External Implant System isintended to be surgically placed in themaxillary or mandibular molar areasfor the purpose providing prostheticsupport for dental restorations(Crown, bridges, and overdentures)in partially or fully edentulousindividuals. It is used to restore apatient's chewing function. Smallerimplants (less than 6.0 mm) arededicated for immediate loading whengood primary stability is achieved and withappropriate occlusal loading.Larger implants are dedicated for themolar region and are indicated fordelayed loading.	The AnyOne Onestage ImplantSystem is intended to besurgically placed in the maxillary ormandibular arches for the purpose ofproviding prosthetic support fordental restorations (Crown,bridges, and overdentures) inpartially or fully edentulousindividuals. It is used to restore apatient's chewing function in thefollowing situations and with theclinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading.Larger implants are dedicated for the molarregion.
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)
SurfaceTreatment	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 <85>.

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.

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.