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.

Device Description

AnyOne External Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance. AnyOne External Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. Dental prosthesis is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is made of Ti-6A1-4V ELI, Gold alloy, CCM alloy and intended to be placed on the fixture allows single & multiple prosthetic restore a patient's chewing function.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AnyOne External Implant System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission details the equivalence to predicate devices rather than explicit, stand-alone acceptance criteria with specific numerical thresholds for each component. However, the core acceptance criteria revolve around demonstrating substantial equivalence to existing, legally marketed devices (predicates and reference devices). The reported performance across all components is that they met the pre-set criteria for the conducted tests.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (following ISO 10993-1) Identical material, manufacturing, and patient-contacting parts as predicate device	The subject device has the same material composition, manufacturing process, and patient contacting parts as predicate and reference devices, indicating it meets biocompatibility.
Surface Treatment (following 'Section 11 of Class II Special Controls Guidance Document...') Identical surface treatment and manufacturing as predicate device	The subject device has the same surface treatment (S.L.A for fixture, Anodizing for abutment, TiN coating for abutment) and manufacturing process as predicate and reference devices.
Pyrogen and Endotoxin Levels (following USP 39 <85>) Endotoxin levels below 0.5 EU/mL	Endotoxin testing will be conducted on every batch with a testing limit of below 0.5 EU/mL. (Note: This is a statement of intent for ongoing quality control, not a direct performance result from the validation study, but implies the acceptance criterion).
Sterility Assurance Level (SAL) (following ISO 11137 and ISO 17665-1, 2) SAL of 10⁻⁶	Sterilization validation tests achieved a sterility assurance level of 10⁻⁶.
Shelf Life (following ASTM F1980) 5 years shelf life	Test results validated a 5-year shelf life using the accelerated aging method.
Performance Tests (following ISO 14801 and 'Class II Special Controls Guidance Document...') Static compression-strength and fatigue tests met pre-set criteria.	The test results met the pre-set criteria for static compression-strength and fatigue tests for all relevant components, demonstrating substantial equivalence to predicate devices.

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

The document does not explicitly state the numerical sample size for the test set used in the performance bench tests (static compression-strength and fatigue tests). It mentions "test was performed on the subject device and predicate device" and "representative specimen".

Sample Size (Test Set): Not explicitly stated as a numerical value for each test (e.g., how many implants were tested for fatigue). It generally refers to "the subject device and predicate device" and "representative specimen" in singular form, implying at least one of each worst-case scenario. However, for a regulatory submission of this nature, multiple samples would typically be tested to establish statistical confidence, even if not explicitly detailed in this summary.
Data Provenance: The study is non-clinical bench testing. The country of origin of the data is not specified, but the applicant and correspondent are located in the Republic of Korea. The tests are prospective as they were conducted specifically for this submission to demonstrate substantial equivalence.

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

This is not applicable as the studies are non-clinical bench tests (physical properties, biocompatibility, sterilization, etc.). Ground truth in this context is established by adherence to recognized international standards (ISO, ASTM, USP) and FDA guidance documents. There is no mention of human experts interpreting test results for "ground truth" in the way it might apply to a clinical study involving medical image analysis, for example.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical bench testing. Passing or failing criteria are determined by adherence to established engineering and material science standards (e.g., force applied, number of cycles, endotoxin concentration limits).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a submission for a dental implant system involving physical components. MRMC studies are typically performed for AI/CAD systems that assist human readers in tasks like medical image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. As above, this is for a physical medical device. There is no algorithm involved.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

Standardized Test Methods: Adherence to international standards such as ISO 14801 for mechanical testing, ISO 10993-1 for biocompatibility, ISO 11137 and ISO 17665-1, 2 for sterilization, ASTM F1980 for shelf life, and USP 39 <85> for endotoxin testing.
Predicate Device Comparison: Substantial equivalence is established by demonstrating that the subject device's performance, materials, and design are comparable to legally marketed predicate and reference devices. The predicate devices themselves serve as a form of "ground truth" for acceptable performance and safety within their intended use.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.

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

Not applicable. See point 8.

Summary

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

MegaGen Implant Co., Ltd. % You Jung Kim Chief Researcher DaeGyeong Regulatory Affairs Institute 32, Innovalley-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA

Re: K203554

Trade/Device Name: AnyOne External Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 30, 2021 Received: July 30, 2021

Dear You Jung Kim:

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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

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 Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K203554

Device Name

AnyOne External Implant System

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-

e-Counter Use (21 CFR 801 Subpart C)

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K203554

510(k) Summary

Date: August 28, 2021

1. Applicant / Submitter

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

2. Submission Correspondent

You Jung Kim DaeGyeong Regulatory affairs Institute 32, Innovalley-ro, Dong-gu, Daegu, 41065, Republic of Korea Fax: +82-53-247-2254 Tel: +82-53-247-2258 Email: ra3@dgri.co.kr

3. Device

▪ Trade Name:	AnyOne External Implant System
▪ Common Name:	Endosseous Dental Implant
▪ Classification Name:	Endosseous dental implant
▪ Classification Product Code:	DZE
▪ Secondary Product Code:	NHA
▪ Classification regulation:	Class II, 21 CFR 872.3640

Predicate Device 4.

. Primary Predicate Device:

K122231 - Xpeed AnyRidge Internal Implant System

. Reference Devices:

K052369 ExFeel Dental Implant System
K123988 AnyOne Internal Implant System
K192347 ST Internal Implant System
K053353 Rescue Dental Implant System
K182448- AnyRidge Octa 1 Implant System
K150537 MiNi Internal Implant System
K192436 Healing Abutments and Cover Screws
K110955 AnyRidge Internal Implant System
K081302 Rescue External Implant System
K160670 ET US SS Prosthetic System
K171142 Healing Cap Multi-Unit Titanium
K182091 Osstem Abutment System

K192614 - Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment

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5. Description

. AnyOne External Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance.
. AnyOne External Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. Dental prosthesis is a superstructure of a dental implant system and connecting elements between the

dental implant and the crown. It is made of Ti-6A1-4V ELI, Gold alloy, CCM alloy and intended to be placed on the fixture allows single & multiple prosthetic restore a patient's chewing function.

			Content
1. Fixture	AnyOneExternalFixture	Description	AnyOne External Fixture is a substructure of a dentalimplant system made of titanium and have the interfaceconnection for External Hex. It is used in conjunction withother prosthetic and restore lost chewing ability, improveappearance.
		Material	CP Ti Grade 4 (ASTM F67-13)
		Dimension(Diameter & Length)	$Ø$ 3.9 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm$Ø$ 4.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm$Ø$ 4.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm$Ø$ 5.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm$Ø$ 5.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm$Ø$ 6.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm$Ø$ 6.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm
2. CoverScrew&HealingAbutment	CoverScrew	Description	The Cover Screw is used in conjunction with fixture forprotecting the inner structure of a fixture, and exposedfixture platform after fixture placement.
		Material	Ti-6A1-4V ELI (ASTM F136-13)
		Dimension(Diameter & Length)	$Ø$ 3.5 x 5.3, 6.2 mm$Ø$ 4.1 x 5.3, 6.2 mm$Ø$ 5.0 x 5.3, 6.2 mm
		Gingival (Cuff) Heights	1.3 mm
		Angulation	Straight

. The proposed AnyOne External Implant System is consisted of the following components. For reference, all the subject device in this submission are to be added Megagen's existing implant and

Screw		protecting the inner structure of a fixture, and exposedfixture platform after fixture placement.
HealingAbutment	Material	Ti-6A1-4V ELI (ASTM F136-13)
	Dimension(Diameter & Length)	Ø 3.5 x 5.3, 6.2 mmØ 4.1 x 5.3, 6.2 mmØ 5.0 x 5.3, 6.2 mm
	Gingival (Cuff) Heights	1.3 mm
	Angulation	Straight
	Description	The Healing Abutment is used in conjunction with fixtureand helps to form suitable emergence profile during periodof gingival healing.
HealingAbutment	Material	Ti-6A1-4V ELI (ASTM F136-13)
	Dimension(Diameter & Length)	Ø 4.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mmØ 5.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mmØ 6.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mmØ 7.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mm
	Gingival (Cuff) Heights	2.0, 3.0, 4.0, 5.0, 7.0 mm
	Angulation	Straight
	Description	The Esthetic Healing Abutment is used in conjunction withfixture and helps to form suitable emergence profile duringperiod of gingival healing. It is helpful to maintain morethickness of soft tissue and easy to make soft tissue closureagainst narrow top.
EstheticHealingAbutment	Material	Ti-6A1-4V ELI (ASTM F136-13)
	Dimension(Diameter & Length)	Ø 3.5 x 6.2, 7.2, 8.2 mmØ 4.1 x 6.2, 7.2, 8.2 mmØ 5.0 x 6.2, 7.2, 8.2 mm
	Gingival (Cuff) Heights	2.5, 3.5, 4.5 mm
	Angulation	Straight

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3. FixtureLevelProsthesis	TemporaryAbutment	Description	The Temporary Abutment is used in conjunction with fixtureto provide support for provisional restoration. It isconnected to the Fixture using Abutment Screw. It has amaximum intra-oral use of 180-days.
		Material	Ti-6A1-4V ELI (ASTM F136-13)
		Dimension(Diameter & Length)	Ø 3.9 x 12.0 mmØ 4.5 x 12.0 mmØ 5.5 x 12.0 mm
		Post Heights	10.0 mm
		Gingival (Cuff) Heights	1.3 mm
		Angulation	Straight
	EZ PostAbutment	Description	The EZ Post Abutment is used in conjunction with fixture toprovide support for cement and screw retained type finalprosthesis. It is connected to the Fixture using AbutmentScrew.
		Material	Ti-6A1-4V ELI (ASTM F136-13)
		Dimension(Diameter & Length)	Ø 4.0 x 10.0, 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
		Post Heights	8.0 mm
		Gingival (Cuff) Heights	1.0, 2.0, 3.0, 4.0 mm
		Angulation	Straight
	AngledAbutment	Description	The Angled Abutment is used in conjunction with fixture andused for correcting the prosthetic angulation of implant. Itis connected to the Fixture using Abutment Screw.
		Material	Ti-6A1-4V ELI (ASTM F136-13)
		Dimension(Diameter & Length)	Ø 4.0 x 9.0, 11.0 mmØ 5.0 x 9.0, 11.0 mmØ 6.0 x 9.0, 11.0 mm
		Post Heights	7.0 mm
		Gingival (Cuff) Heights	2.0, 4.0 mm
		Angulation	15°, 25°
	MillingAbutment	Description	The Milling Abutment is used in conjunction with fixture andused for establishing an adequate safety margin fromocclusal line by hand milling of the post part. It is connectedto the Fixture using Abutment Screw.(Note. Only be for Hand Milling with no CAD/CAM)
		Material	Ti-6A1-4V ELI (ASTM F136-13)
		Dimension(Diameter & Length)	Ø 4.0 x 11.0, 13.0 mmØ 5.0 x 10.0, 11.0, 12.0, 13.0 mmØ 6.0 x 10.0, 11.0, 12.0, 13.0 mmØ 7.0 x 10.0, 11.0, 12.0, 13.0 mm
		Post Heights	9.0 mm
		Gingival (Cuff) Heights	1.0, 2.0, 3.0, 4.0 mm
		Angulation	Straight
	GoldAbutment	Description	The Gold Abutment is used in conjunction with fixture andused for fabrication of abutment for either screw or cementretained restorations by casting with precious metal alloy. Itis connected to the Fixture using Abutment Screw.
		Material	Body: Gold Alloy / Sleeve: POM
		Dimension(Diameter & Length)	Ø 4.0 x 11.0 mmØ 4.5 x 11.2 mmØ 5.5 x 11.2 mm
		Post Height	10.0 mm
		Gingival (Cuff) Heights	1.0, 1.2 mm
		Angulation	Straight
	AbutmentScrew	Description	The Abutment Screw is used for connecting Fixture toTemporary Abutment, EZ Post Abutment, AngledAbutment, Milling Abutment or Gold Abutment.
		Material	Ti-6A1-4V ELI (ASTM F136-13)
				Dimension(Diameter & Length)	Dimension(Diameter & Length)	Ø 2.5 x 7.5 mm
4.AbutmentLevelProsthesis	RegularAbutment	Description	The Regular Abutment is used in conjunction with fixtureand used for fabrication of either screw or cement retainedprosthetics. It is connected to the Fixture using RegularAbutment Screw.
		Material	Ti-6A1-4V ELI (ASTM F136-13)
		Dimension(Diameter & Length)	Ø 4.5 x 3.0, 4.0, 5.5, 7.0, 8.5 mmØ 4.8 x 3.0, 3.8, 4.8, 5.8 mm
		Post Heights	1.8 mm

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	Gingival (Cuff) Heights	1.2, 2.0, 3.0, 4.0 mm
	Angulation	Straight
RegularAbutmentScrew	Description	The Regular Abutment Screw is used for connecting Fixtureto Regular Abutment.
	Material	Ti-6A1-4V ELI (ASTM F136-13)
	Dimension(Diameter & Length)	$Ø$ 2.95 x 8.85, 9.85, 10.85, 11.85 mm$Ø$ 3.5 x 7.9, 9.05, 10.55, 12.05, 13.55 mm
Multi-unitAbutment	Description	The Multi-unit Abutment is used in conjunction with fixtureto fabricate screw-retained prosthesis. It is two-piece typeand connected the fixture with Multi-unit Abutment Screw.
	Material	Ti-6A1-4V ELI (ASTM F136-13)
	Dimension(Diameter & Length)	$Ø$ 4.8 x 2.0, 3.0, 4.0, 5.0, 6.0 mm
	Post Heights	1.0 mm
	Gingival (Cuff) Heights	1.0, 2.0, 3.0, 4.0, 5.0 mm
	Angulation	Straight
Multi-unitAngledAbutment	Description	The Multi-unit Angled Abutment is used in conjunction withfixture for fabricating screw-retained prosthesis andcorrecting the prosthetic angulation of implant. It is two-piece type and connected the fixture with Multi-unitAbutment Screw.
	Material	Ti-6A1-4V ELI (ASTM F136-13)
	Dimension(Diameter & Length)	$Ø$ 4.8 x 3.65, 4.65, 5.13, 5.65, 6.13 mm
	Post Heights	2.2 mm
	Gingival (Cuff) Heights	2.0, 3.0, 4.0, 5.0 mm
	Angulation	17°, 30°
Multi-unitAbutmentScrew	Description	The Multi-unit Abutment Screw is used for connectingMulti-unit Abutment or Multi-unit Angled Abutment to thefixture.
	Material	Ti-6A1-4V ELI (ASTM F136-13)
	Dimension(Diameter & Length)	$Ø$ 2.4 x 6.8 mm$Ø$ 2.9 x 6.7, 7.7, 8.7, 9.7, 10.7 mm
Healing Cap	Description	The Healing Cap is used for protecting Regular Abutment orMulti-unit (Angled) Abutment and minimizing irritation totongue and oral mucosa during period of gingival healing. Itis connected to the Abutment using its threaded part orCylinder Screw. It has a maximum intra-oral use of 180-days.
	Material	Ti-6A1-4V ELI (ASTM F136-13)
	Dimension(Diameter & Length)	$Ø$ 4.9 x 4.2 mm$Ø$ 5.0 x 6.1 mm$Ø$ 6.8 x 4.2 mm
TemporaryAbutment	Description	The Temporary Abutment is used in conjunction withRegular Abutment to provide support for provisionalrestoration. It is connected to the Abutment usingAbutment Screw. It has a maximum intra-oral use of 180-days.
	Material	Ti-6A1-4V ELI (ASTM F136-13)
	Dimension(Diameter & Length)	$Ø$ 4.8 x 12.35 mm
	Post Heights	7.5 mm
	Gingival (Cuff) Heights	2.8 mm
TemporaryCylinder	Angulation	Straight
	Description	The Temporary Cylinder is used in conjunction with Multi-unit (Angled) Abutment to provide support for provisionalrestoration. It is connected to the Abutment using CylinderScrew. It has a maximum intra-oral use of 180-days.
	Material	Ti-6A1-4V ELI (ASTM F136-13)
	Dimension(Diameter & Length)	$Ø$ 4.8 x 12.0 mm
	Post Heights	8.5 mm
	Gingival (Cuff) Heights	3.0 mm
	Angulation	Straight
EZ PostCylinder	Description	The EZ Post Cylinder is used in conjunction with RegularAbutment to provide support for cement and screw typefinal prosthesis. It is connected to the Abutment usingAbutment Screw.
	Dimension(Diameter & Length)	Material	$\unicode{x2300}$ 5.0 x 8.5 mm	Ti-6A1-4V ELI (ASTM F136-13)
		Post Heights	7.7 mm
		Gingival (Cuff) Heights	0.8 mm
		Angulation	Straight
	GoldCylinder	Description	The Gold Cylinder is used in conjunction with RegularAbutment to provide support for screw type final prosthesisby casting with precious metal alloy. It is connected to theAbutment using Abutment Screw.
		Material	Body: Gold Alloy / Sleeve: POM
		Dimension(Diameter & Length)	Ø 4.8 x 13.0 mm
		Post Heights	10.0 mm
		Gingival (Cuff) Heights	3.0 mm
		Angulation	Straight
	CCMCylinder	Description	The CCM Cylinder is used in conjunction with RegularAbutment or with Multi-unit (Angled) Abutment to providesupport for screw type final prosthesis by casting with non-precious metal alloy. It is connected to the Abutment usingAbutment Screw or Cylinder Screw.
		Material	Body: Co-Cr-Mo Alloy / Sleeve: POM
		Dimension(Diameter & Length)	Ø 4.8 x 13.0, 15.0 mm
		Post Heights	10.0, 13.0 mm
		Gingival (Cuff) Heights	2.0, 3.0 mm
		Angulation	Straight
	DescriptionAbutmentScrew		The Abutment Screw is used for connecting RegularAbutment to Temporary Abutment, EZ Post Cylinder, GoldCylinder or CCM Cylinder.
		Material	Ti-6A1-4V ELI (ASTM F136-13)
		Dimension(Diameter & Length)	Ø 2.45 x 4.8 mm
	CylinderScrew	Description	The Cylinder Screw is used for connecting Multi-unit(Angled) Abutment to Healing Cap, Temporary Cylinder orCCM Cylinder.
		MaterialDimension(Diameter & Length)	Ti-6A1-4V ELI (ASTM F136-13)Ø 2.0 x 3.4 mm
5. OverdentureProsthesis	Meg-RheinAbutment	Description	The Meg-Rhein Abutment is used in conjunction with fixtureand used to restore the patient's masticatory function bysupporting the prosthesis such as artificial teeth and isintended to fixate and stabilize the removable dentureexactly by connecting fixture and Denture. It is connected tothe Fixture using its threaded part.
		Material	Ti-6A1-4V ELI (ASTM F136-13)
		Dimension(Diameter & Length)	Ø 3.5 x 7.9, 9.9, 11.9 mm
			Ø 4.1 x 7.9, 9.9, 11.9 mm
			Ø 5.0 x 7.9, 9.9, 11.9 mm
		Post Heights	1.7 mm
		Gingival (Cuff) Heights	2.0, 4.0, 6.0 mm
		Angulation	Straight

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[Note. 1] Some of devices described in this submission had been FDA cleared with K052369 and K123988, but it is being submitted to change their identifier with modification of product name or material, and to add new dimensions as followings. The changes are explained not affecting substantial equivalence in this 510(k) Submission.

No.	510(k) No.	Predicate Device		Subject Device		Change
		Product Name	Material	Product Name	Material
1	K052369	Cover Screw	CP Ti Grade 3	Cover Screw	Ti-6A1-4V ELI	- Material- New modelsare added
2	K052369	HealingAbutment	CP Ti Grade 3	Healing Abutment	Ti-6A1-4V ELI	- Material- New modelsare added
3	K052369	CementAbutment	CP Ti Grade 3	EZ Post Abutment	Ti-6A1-4V ELI	- Material- Product Name
4	K052369	UCLA GoldAbutment	No change	Gold Abutment	No change	- Product Name
5	K052369	Coping Screw	No change	Abutment Screw	No change	- Product Name
6	K052369	RegularAbutment	CP Ti Grade 3	Regular Abutment	Ti-6A1-4V ELI	- Material
7	K052369	RegularAbutment Screw	CP Ti Grade 3	RegularAbutment Screw	Ti-6A1-4V ELI	- Material
8	K052369 K123988	Healing CapOcta Healing Cap	CP Ti Grade 3Ti-6A1-4V ELI	Healing Cap	Ti-6A1-4V ELI	- Product Name- Material- New modelsare added
9	K052369 K123988	TemporaryCylinderTemporaryCylinder	CP Ti Grade 3CP Ti Grade 4	TemporaryAbutment	Ti-6A1-4V ELI	- Product Name- Material- New modelsare added
10	K052369 K123988	Conical AbutmentEZ Post Cylinder	CP Ti Grade 3CP Ti Grade 4	EZ Post Cylinder	Ti-6A1-4V ELI	- Product Name- Material
11	K052369	Temporary(Cylinder) Screw	No change	Abutment Screw	No change	- Product Name

[Note. 2] The following device described in this submission also had been FDA cleared with K123988, but it is being submitted to change their identifier only without any modification.

	Predicate Device		Subject Device
No.	510(k) No.	Product Name	Product Name	Change
1	K123988	Gold Cylinder	Gold Cylinder	N/A

{9}------------------------------------------------

6. Indication for use

7. Basis for Substantial Equivalence

The AnyOne External Implant System is substantially equivalent to the predicate devices in terms of indication for use, technical characteristic and function. They are made of the same material and have similar design. Performance test of subject device demonstrated the minor difference in size range did not affect substantial equivalence.

The Indications for Use for the subject devices is identical to the primary predicate, K122231 and the reference device, K123988.

In order to demonstrate the difference in design and size ranges does not raise any new issues, the performance test on the subject and predicate device have been performed in consideration of the worst case according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. The test result supports the substantial equivalence to the predicate devices.

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

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

AnyOne External Fixture

	Subject Device	Predicate Device	Reference Device 1	Reference Device 2
510(k) No.	K203554	K122231	K052369	K123988
Device Name(CompatibleImplantSystem)	AnyOne ExternalFixtureFor AnyOne External ImplantSystem	XPEED AnyRidgeInternal FixtureFor Xpeed AnyRidge InternalImplant System	ExFeel External FixtureFor ExFeel Dental ImplantSystem	AnyOne Internal FixtureFor AnyOne Internal ImplantSystem
Manufacturer	MegaGen Implant Co.,Ltd.	MegaGen Implant Co.,Ltd.	MegaGen Implant Co.,Ltd.	MegaGen Implant Co.,Ltd.
Indicationsfor UseStatement	The AnyOne ExternalImplant System isintended to be surgicallyplaced in the maxillary ormandibular molar areasfor the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulous individuals.It is used to restore apatient's chewingfunction. 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.	The Xpeed AnyRidgeInternal Implant Systemis intended to besurgically placed in themaxillary or mandibularmolar areas for thepurpose providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) inpartially or fuillyedentulous individuals.It is used to restore apatient's chewingfunction. Smallerimplants (less than 06.0mm) are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for themolar region and areindicated for delayedloading.	The ExFeel DentalImplant Systems areintended to be placed inthe upper or lower jawto support prostheticdevices, such as artificialteeth, and to restore apatient's chewingfunction. This may beaccomplished usingeither a two stagesurgical procedure or asingle stage surgicalprocedure.	The AnyOne InternalImplant System isintended to be surgicallyplaced in the maxillary ormandibular molar areasfor the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulous individuals.It is used to restore apatient's chewingfunction. Smaller implants (lessthan 06.0 mm) arededicated for immediateloading when goodprimary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for themolar region and areindicated for delayedloading.
Design	Image: Design of AnyOne External Fixture	Image: Design of XPEED AnyRidge Internal Fixture	Image: Design of ExFeel External Fixture	Image: Design of AnyOne Internal Fixture
Diameter (Ø)&Total Length	Ø3.9 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ4.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ4.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ5.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ5.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ6.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ6.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mm	Ø4.0 x 7.2, 9.2, 10.7,12.2, 14.2, 17.2 mmØ4.4 x 7.2, 9.2, 10.7,12.2, 14.2, 17.2 mmØ4.9 x 7.2, 9.2, 10.7,12.2, 14.2, 17.2 mmØ5.4 x 7.2, 9.2, 10.7,12.2, 14.2, 17.2 mmØ5.9 x 7.2, 9.2, 10.7,12.2, 14.2, 17.2 mmØ6.4 x 7.9, 9.4, 10.9,12.4, 14.4 mmØ6.9 x 7.9, 9.4, 10.9,12.4, 14.4 mmØ7.4 x 7.9, 9.4, 10.9,12.4, 14.4 mmØ7.9 x 7.9, 9.4, 10.9,12.4, 14.4 mmØ8.4 x 7.9, 9.4, 10.9,12.4, 14.4 mm	Ø3.25 x 8.1, 9.6, 11.1,12.6, 14.6, 17.6 mmØ3.7 x 8.1, 9.6, 11.1,12.6, 14.6, 17.6 mmØ3.95 x 8.1, 9.6 mmØ4.0 x 11.1, 12.6 14.6,17.6 mmØ4.95 x 8.1, 9.6, 11.1,12.6, 14.6 mm	Ø3.9 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ4.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ4.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ5.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ5.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ6.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ6.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ7.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ7.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ8.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mm
Implant-toAbutmentConnection	External Hex	Internal ConicalConnection,Internal Hex	External Hex	Internal Hex
Material	CP Ti Grade 4(ASTM F67-13)	CP Ti Grade 4(ASTM F67-13)	CP Ti Grade 3(ASTM F67-13)	CP Ti Grade 4(ASTM F67-13)
Single Use	Yes	Yes	Yes	Yes
SurfaceTreatment	Sand-blasted, Large grit,Acid-etched (SLA)	Sand-blasted, Large grit,Acid-etched (SLA)	Sand-blasted (RBM)	Sand-blasted, Largegrit, Acid-etched (SLA)
Sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization
Shelf Life	5 years	5 years	5 years	5 years
Feature	- Submerged Implant- Straight / Taperedbody shape- cutting edge with self-tapping- 0.8mm thread pitch	- Submerged Implant- Straight / Taperedbody shape- cutting edge with self-tapping- 0.8mm thread pitch	- Submerged Implant- Straight / Taperedbody shape- cutting edge with self-tapping- 0.5mm & 0.6mmthread pitch	- Submerged Implant- Straight / Taperedbody shape- cutting edge with self-tapping- 0.8~1.55mmthread pitch
Principle ofOperation	It is a tapered bodyfixture which is insertedin the alveolar bone.It replaces the functionsof the missing teeth as adental implant fixture.	It is a tapered bodyfixture which is insertedin the alveolar bone.It replaces the functionsof the missing teeth as adental implant fixture.	It is a tapered bodyfixture which is insertedin the alveolar bone.It replaces the functionsof the missing teeth as adental implant fixture.	It is a tapered bodyfixture which is insertedin the alveolar bone.It replaces the functionsof the missing teeth as adental implant fixture.
Substantial Equivalence Discussion

{11}------------------------------------------------

1. Similarities

The subject device has the same characteristic for the followings compared to the predicate device. Indication for use, Design, Material, Single Use, Surface Treatment, Sterilization, Shelf Life, Feature and Principle of Operation.

2. Differences

Diameter & Total Length

The Diameter and Total Length of subject device is slightly different with predicate device but all the subject combination of diameter and length is within the range of the dimension combination of reference device 2. -Connection

The subject device has External Hex connection while the predicate device has Internal Hex connection, but has same connection structure as Megagen's FDA cleared reference device 1.

ന് Discussion

The proposed AnyOne External Fixture and predicate device have common in Indication for use, Design, Material, Single Use, Surface Treatment, Sterilization, Shelf Life, Feature and Principle of Operation. The differences are explained not affecting on the substantial equivalence, but the fatigue test was performed on the subject device and predicate device to confirm the substantial equivalence, with combination of the worst case design fixture and abutment, according to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment". The test result supports that the subject device is substantially equivalent to the predicate device and the differences are not affecting the substantial equivalence.

{12}------------------------------------------------

Cover Screw

	Subject Device	Reference Device 1	Reference Device 2
510(k) No.	K203554	K052369	K192347
Device Name(CompatibleImplant System)	Cover ScrewFor AnyOne External Implant System	Cover ScrewFor ExFeel Dental Implant System	Cover ScrewFor ST Internal Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUseStatement	The AnyOne External Implant Systemis intended 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 function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region and areindicated for delayed loading.	The ExFeel Dental Implant Systems areintended to be placed in the upper orlower jaw to support prostheticdevices, such as artificial teeth, and torestore a patient's chewing function.This may be accomplished using eithera two stage surgical procedure or asingle stage surgical procedure.	The ST Internal Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose providing prosthetic supportfor dental restorations (Crown,bridges, and overdentures) in partiallyor fully edentulous individuals. It isused to restore a patient's chewingfunction. Smaller implants (less than6.0 mm) are dedicated for immediateloading when good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region and areindicated for delayed loading.
Design	Image: Design	Image: Design	Image: Design
Diameter (Ø)	3.5, 4.1, 5.0 mm	3.5, 4.1, 5.0 mm	3.1, 3.6 mm
Total Length	5.3, 6.2 mm	6.2 mm	5.3, 5.9 mm
GingivalHeight	1.3 mm	1.3 mm	0.4 mm
ConnectionInterface	Internal Conical Connection	Internal Conical Connection	Internal Conical Connection
Material	Ti-6A1-4V ELI(ASTM F136-13)	CP Ti Grade 3(ASTM F67-13)	Ti-6A1-4V ELI(ASTM F136-13)
SurfaceTreatment	Anodizing, Machined	Anodizing	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization
Principle ofOperation	The Cover Screw is used forprotecting the inner structure of afixture, and exposed fixtureplatform after fixture placement.	The Cover Screw is used forprotecting the inner structure of afixture, and exposed fixtureplatform after fixture placement.	The Cover Screw is used forprotecting the inner structure of afixture, and exposed fixtureplatform after fixture placement.
Substantial Equivalence Discussion
1. SimilaritiesThe subject device has the same characteristic for the followings compared to the reference device 1.Indication for use, Design, Diameter, Gingival Height, Connection Interface, Surface Treatment, Single Use,Sterilization and Principle of Operation

2. Differences

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

-Total Length
The length of subject device is slightly different with reference device 1, but one of length(6.2mm) is same as reference device 1, and the other one(5.3mm) is same as reference device 2.

-Material

The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure titanium, but has made with same material with reference device 2. Also, the leveraged materials are being used for similar devices and intended uses.

Discussion ന്

Some of proposed Cover Screw had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of the material only, and to add new models. Therefore, the proposed Cover Screw and reference device 1 have common in Indication for use, Design, Diameter, Gingival Height, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.

{13}------------------------------------------------

Healing Abutment

	Subject Device	Reference Device 1	Reference Device 2
510(k) No.	K203554	K052369	K053353
Device Name(CompatibleImplant System)	Healing AbutmentFor AnyOne External Implant System	Healing AbutmentFor ExFeel Dental Implant System	Healing AbutmentFor Rescue Dental Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUseStatement	The AnyOne External Implant Systemis intended 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 function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region and areindicated for delayed loading.	The ExFeel Dental Implant Systems areintended to be placed in the upper orlower jaw to support prostheticdevices, such as artificial teeth, and torestore a patient's chewing function.This may be accomplished using eithera two stage surgical procedure or asingle stage surgical procedure.	The Rescue® 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. These implants areintended to be used where smallerimplants have failed.
Design
Diameter (Ø)	4.0, 5.0, 6.0, 7.0 mm	4.0, 5.0, 6.0, 7.0 mm	6.0, 8.0, 10.0 mm
Total Length	6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8,10.7, 11.8, 12.7 mm	7.7, 8.7, 9.7, 10.7, 12.7 mm	6.3, 7.3, 8.3, 9.3, 10.3, 11.3 mm
GingivalHeight	2.0, 3.0, 4.0, 5.0, 7.0 mm	2.0, 3.0, 4.0, 5.0, 7.0 mm	2.0, 3.0, 4.0, 5.0, 6.0, 7.0 mm
Angulation	Straight	Straight	Straight
ConnectionInterface	Internal Conical Connection	Internal Conical Connection	Internal Conical Connection
Material	Ti-6A1-4V ELI(ASTM F136-13)	CP Ti Grade 3(ASTM F67-13)	CP Ti Grade 3(ASTM F67-13)
SurfaceTreatment	Anodizing, Machined	Anodizing, Machined	Machined
Single Use	Yes	Yes	Yes
Sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization
Principle ofOperation	The Healing Abutment is fastenedinto the female screw of dentalimplant and support the gingivalshaping.	The Healing Abutment is fastenedinto the female screw of dentalimplant and support the gingivalshaping.	The Healing Abutment is fastenedinto the female screw of dentalimplant and support the gingivalshaping.
Substantial Equivalence Discussion
	Subject Device	Reference Device 1	Reference Device 2	Reference Device 3
510(k) No.	K203554	K182448	K150537	K192436
Device Name(CompatibleImplant System)	Esthetic HealingAbutmentFor AnyOne External ImplantSystem	Healing AbutmentFor AnyRidge Octa 1 ImplantSystem	Healing AbutmentFor MiNi Internal ImplantSystem	Healing AbutmentFor Healing Abutments andCover Screws
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	Dentium Co., Ltd.
Indications forUseStatement	The AnyOne ExternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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.	The AnyRidge Octa 1Implant System is intendedto be surgically placed inthe maxillary or mandibulararches for the purpose ofproviding 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 is achievedand with appropriateocclusal loading. Largerimplants are dedicated forthe molar region.	The MiNi Internal ImplantSystem is intended for two-stage surgical proceduresin the following situationsand with the followingclinical protocols:- The intended use for the3.0 mm diameter MiNiimplant is limited to thereplacement ofmaxillary lateral incisorsand mandibular incisors.- Immediate placement inextraction sites and insituations with a partiallyor completelyhealed alveolar ridge.- It is intended for delayedloading.	Dentium Prosthetics areintended for use as an aidin prosthetic rehabilitation.
Design	Image: Design	Image: Design	Image: Design	Image: Design
Diameter (Ø)	3.5, 4.1, 5.0 mm	3.2, 4.2, 5.2, 6.2 mm	3.2, 3.7 mm	4.8, 6.5 mm
Total Length	6.2, 7.2, 8.2 mm	8.6, 9.6, 10.6, 11.6,12.6, 13.6, 14.6, 15.6mm	6.3, 6.8, 7.8, 8.8, 9.8mm	6.15, 6.30, 7.15, 7.30,8.15, 8.30, 9.15, 9.30mm
GingivalHeight	2.5, 3.5, 4.5 mm	2.5, 3.5, 4.5, 5.5, 6.5,7.5, 8.5, 9.5 mm	2.3, 2.8, 3.8, 4.8, 5.8mm	Not Known
Angulation	Straight	Straight	Straight	Straight
ConnectionInterface	Internal ConicalConnection	Internal ConicalConnection	Internal ConicalConnection	Internal ConicalConnection
Material	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6A1-4V ELI(ASTM F136-13)
SurfaceTreatment	Anodizing, Machined	Anodizing	Machined	Machined
Single Use	Yes	Yes	Yes	Yes
Sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization
Principle ofOperation	The Esthetic HealingAbutment is fastened intothe female screw of dentalimplant and support thegingival shaping.	The Healing Abutment isfastened into the femalescrew of dental implant andsupport the gingivalshaping.	The Healing Abutment isfastened into the femalescrew of dental implant andsupport the gingivalshaping.	The Healing Abutment isfastened into the femalescrew of dental implant andsupport the gingivalshaping.
Substantial Equivalence Discussion
1. SimilaritiesThe subject device has the same characteristic for the followings compared to the reference device 1.
	Subject Device	Reference Device 1	Reference Device 2	Reference Device 3
510(k) No.	K203554	K052369	K053353	K150537
Device Name(CompatibleImplant System)	Temporary AbutmentFor AnyOne ExternalImplant System	Temporary CylinderFor ExFeel Dental ImplantSystem	UCLA TemporaryAbutmentFor Rescue Dental ImplantSystem	Temporary AbutmentFor MiNi Internal ImplantSystem
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUseStatement	The AnyOne ExternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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.	The ExFeel Dental ImplantSystems are intended to beplaced in the upper orlower jaw to supportprosthetic devices, such asartificial teeth, and torestore a patient's chewingfunction. This may beaccomplished using eithera two stage surgicalprocedure or a single stagesurgical procedure.	The Rescue® ImplantSystem is intended to besurgically placed in themaxillary or mandibularmolar areas for thepurpose providingprosthetic support fordental restorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals.These implants areintended to be used wheresmaller implants havefailed.	The MiNi Internal ImplantSystem is intended for two-stage surgical proceduresin the following situationsand with the followingclinical protocols:- The intended use for the3.0 mm diameter MiNiimplant is limited to thereplacement ofmaxillary lateral incisorsand mandibular incisors.- Immediate placement inextraction sites and insituations with a partiallyor completelyhealed alveolar ridge.- It is intended for delayedloading.
Design
Diameter (Ø)	3.9, 4.5, 4.8, 5.5 mm	4.8 mm	5.5, 6.5 mm	3.0 mm
Total Length	12.0, 12.35 mm	12.35 mm	12.0 mm	13.8, 14.2 mm
Post Height	7.5, 10.0 mm	7.5 mm	10.0 mm	8.5 mm
Gingival (Cuff)Height	1.3, 2.8 mm	2.8 mm	1.3 mm	2.3 mm
Angulation	Straight	Straight	Straight	Straight
Connection	External Hex,	External Hex,	External Hex,	Internal Hex,
Interface	External Non-Hex	External Non-Hex	External Non-Hex	Internal Non-Hex
Material	Ti-6A1-4V ELI(ASTM F136-13)	CP Ti Grade 3(ASTM F67-13)	CP Ti Grade 3(ASTM F67-13)	Ti-6A1-4V ELI(ASTM F136-13)
SurfaceTreatment	Machined	Machined	Machined	Machined
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The TemporaryAbutment is asuperstructure which isconnected to theFixtures or RegularAbutment using theAbutment Screw.It is used to providesupport for provisionalrestoration.	The Temporary Cylinderis a superstructurewhich is connected tothe Abutment using theScrew.It is used to providesupport for provisionalrestoration.	The TemporaryAbutment is asuperstructure which isconnected to theFixtures using the Screw.It is used to providesupport for provisionalrestoration.	The TemporaryAbutment is asuperstructure which isconnected to theFixtures using the Screw.It is used to providesupport for provisionalrestoration.
Substantial Equivalence Discussion
1. Similarities- The subject device has the same characteristic for the followings compared to the reference device 1.Indication for use, Design, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization andPrinciple of Operation2. DifferencesThe subject device has the different characteristic for the followings compared to the reference device 1.

1. Similarities

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

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

2. Differences

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

Total Length -
The length of subject device is slightly different with reference device 1, but the half are same as reference device 1, and the other half are lie within combined range of reference device 1 & 2.
-Material
The subject device is made of titanium alloy while the reference devices are made entirely of commercially pure titanium, the leveraged materials are being used for similar devices and intended uses.

ന് Discussion

Some of proposed Healing Abutment had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of the material only, and to add new models. Therefore, the proposed Healing Abutment and reference device 1 have common in Indication for use, Design, Diameter, Gingival Height, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.

{14}------------------------------------------------

Esthetic Healing Abutment

-Indication for use, Design, Gingival Height, Angulation, Connection Interface, Material, Single Use, Sterilization and Principle of Operation

Differences

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

Diameter & Total Length -

The dimension of subject device is slightly different with reference device 1 but the dimension of subject device lies within combined range of reference devices.

ന് Discussion

The proposed Esthetic Healing Abutment and reference device 1 have common in Indication for use, Design, Gingival -Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.

{15}------------------------------------------------

Temporary Abutment

-Diameter
The diameter of subject device is slightly different with reference device 1, but all the diameters of subject device lie within range of reference devices.
Total Length, Post Height, Gingival (Cuff) Height

These dimensions are same as reference device 1 and reference device 2.

{16}------------------------------------------------

Material -

The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure titanium, but has made with same material with reference device 3. Also, the leveraged materials are being used for similar devices and intended uses.

ന് Discussion -

Some of proposed Temporary Abutment had been FDA cleared with K052639 and K123988 with product name of 'Temporary Cylinder', but it is being submitted to change their identifier with modification of product name and material, and to add new models. Therefore, the proposed Temporary Abutment and reference device 1 have common in Indication for use, Design, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is a straight type and temporarily used.

{17}------------------------------------------------

EZ Post Abutment

	Subject Device	Reference Device 1	Reference Device 2
510(k) No.	K203554	K052369	K192347
Device Name(CompatibleImplant System)	EZ Post AbutmentFor AnyOne External Implant System	Cement AbutmentFor ExFeel Dental Implant System	EZ Post AbutmentFor ST Internal Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne External Implant Systemis intended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprostheticsupportfor dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primarystability isachievedandwithappropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading.	The ExFeel Dental Implant Systemsare intended to be placed in theupper or lower jaw to supportprosthetic devices, such as artificialteeth, and to restore a patient'schewing function. This may beaccomplished using either a twostage surgical procedure or a singlestage surgical procedure.	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 withappropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading.
Design
Diameter (Ø)	4.0, 5.0, 6.0 mm	4.0, 5.0, 6.0 mm	4.6, 5.0, 6.0, 7.0 mm
Total Length	9.0, 10.0, 11.0, 12.0 mm	9.0, 10.0, 11.0, 12.0 mm	7.5, 8.5, 9.0, 9.1, 9.5, 10.0, 10.1,10.5, 10.6, 11.0, 11.1, 11.5, 11.6,12.0, 12.1, 12.5, 12.6, 13.0, 13.1,13.5, 13.6, 14.5 mm
Post Height	8.0 mm	8.0 mm	4.0, 5.5, 7.0 mm
Gingival Height	1.0, 2.0, 3.0, 4.0 mm	1.0, 2.0, 3.0, 4.0 mm	1.0, 2.0, 3.0, 4.0, 5.0 mm
Angulation	Straight	Straight	Straight
ConnectionInterface	External Hex, External Non-Hex	External Hex, External Non-Hex	Internal Hex, Internal Non-Hex
Material	Ti-6A1-4V ELI (ASTM F136-13)	CP Ti Grade 3 (ASTM F67-13)	Ti-6A1-4V ELI (ASTM F136-13)
SurfaceTreatment	Anodizing	Anodizing	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The EZ Post Abutment is asuperstructure which is connected tothe Fixtures using the AbutmentScrew. It replaces the functions ofthe missing teeth as a dentalabutment.	The Cement Abutment is asuperstructure which is connected tothe Fixtures using the Abutment Screw. It replaces the functions ofthe missing teeth as a dentalabutment.	The EZ Post Abutment is asuperstructure which is connected tothe Fixtures using the AbutmentScrew. It replaces the functions ofthe missing teeth as a dentalabutment.
Substantial Equivalence DiscussionSimilarities
	Subject Device	Reference Device 1	Reference Device 2
510(k) No.	K203554	K110955	K052369
Device Name(CompatibleImplant System)	Angled AbutmentFor AnyOne External Implant System	Angled AbutmentFor AnyRidge Internal ImplantSystem	Cement AbutmentFor ExFeel Dental Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne External Implant Systemis intended 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 function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading.	The AnyRidge Internal ImplantSystem is intended to be surgicallyplaced in the maxillary or mandibularmolar areas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading.	The ExFeel Dental Implant Systemsare intended to be placed in theupper or lower jaw to supportprosthetic devices, such as artificialteeth, and to restore a patient'schewing function. This may beaccomplished using either a twostage surgical procedure or a singlestage surgical procedure.
Design
Diameter (Ø)	4.0, 5.0, 6.0 mm	4.0, 5.0, 6.0, 7.0 mm	4.0, 5.0, 6.0 mm
Total Length	9.0, 11.0 mm	11.4, 12.4, 13.4, 14.4 mm	9.0, 10.0, 11.0, 12.0 mm
Post Height	7.0 mm	7.0 mm	8.0 mm
Gingival Height	2.0, 4.0 mm	1.8, 2.8, 3.8, 4.8 mm	1.0, 2.0, 3.0, 4.0 mm
Angulation	15°, 25°	15°, 25°	Straight
Connection	External Hex,	Internal Hex,	External Hex,
Interface	External Non-Hex	Internal Non-Hex	External Non-Hex
Material	Ti-6A1-4V ELI (ASTM F136-13)	Ti-6A1-4V ELI (ASTM F136-13)	CP Ti Grade 4 (ASTM F67-13)
SurfaceTreatment	Anodizing	Anodizing	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Angled Abutment is asuperstructure which isconnected to the fixtures usingthe Abutment Screw. It replacesthe functions of the missing teethas a dental abutment.	The Angled Abutment is asuperstructure which isconnected to the fixtures usingthe Abutment Screw. It replacesthe functions of the missing teethas a dental abutment.	The Cement Abutment is asuperstructure which isconnected to the fixtures usingthe Abutment Screw. It replacesthe functions of the missing teethas a dental abutment.
Substantial Equivalence Discussion
1. SimilaritiesThe subject device has the same characteristic for the followings compared to the reference device 1.Indication for use, Design, Diameter, Post Height, Angulation, Material, Surface Treatment, Single Use, Sterilizationand Principle of Operation2. DifferencesThe subject device has the different characteristic for the followings compared to the reference device 1.Total Length, Gingival Height- The Total Length of subject device is slightly shorter than reference device 1, but it is due to the connection difference,and all the Lengths of subject device lie within range of reference device 2.The Gingival Height of subject device is slightly different with reference device 1, but all the Gingival Heights of subjectdevice lie within combined range of reference devices.Also, these do not cause a matter in substantial equivalence since the size difference is very minor, and the variety ofthe size can be possible to operate more precise treatment to meet each patient's condition.Connection InterfaceThe subject device has External Hex connection while the reference device 1 has Internal Hex connection, but hassame connection structure as reference device 2. Also, the multiple predicate & reference devices for External Hexconnection are presented in the other component comparison charts.

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

Indication for use, Design, Diameter, Total Length, Gingival Height, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation.

2. Differences

The subject device has the different characteristic for the followings compared to the reference device 1.
Material -
- The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure titanium, but has made with same material with reference device 2. Also, the leveraged materials are being used for similar devices and intended uses.

ന് Discussion

The proposed EZ Post Abutment had been FDA cleared under K052639 with product name of 'Cement Abutment', but it is being submitted to change their identifier with modification of product name and material. Therefore, the proposed EZ Post Abutment and reference device 1 have common in Indication for use, Design, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The material difference is explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type.

{18}------------------------------------------------

Angled Abutment

{19}------------------------------------------------

Discussion ന്

The proposed Angled Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared as with reference device 1. Therefore, the proposed Angled Abutment and reference device 1 have common in Indication for use, Design, Diameter, Post Height, Angulation, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence, but the fatigue test was performed on the subject device 1 to confirm the substantial equivalence. The subject device (Angled Abutment) has been selected as the representative specimen in this submission under the consideration of worst case in accordance with 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. The test result supports that the subject device is substantially equivalent to the reference device 1 and the differences are not affecting the substantial equivalence.

{20}------------------------------------------------

Milling Abutment

	Subject Device	Reference Device 1	Reference Device 2
510(k) No.	K203554	K081302	K192347
Device Name(CompatibleImplant System)	Milling AbutmentFor AnyOne External Implant System	Milling AbutmentFor Rescue External Implant System	Milling AbutmentFor ST Internal Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne External Implant Systemis intended 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 function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading.	The Rescue External Implant Systemis intended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. Theseimplants are intended to be usedwhere smaller implants have failed.	The ST Internal Implant System isintended to be surgically placed in themaxillary or mandibular arches forthe 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 subject device	Image: Design of reference device 1	Image: Design of reference device 2
Diameter (Ø)	4.0, 5.0, 6.0, 7.0 mm	6.0, 7.0 mm	4.0, 5.0, 6.0, 7.0 mm
Total Length	10.0, 11.0, 12.0, 13.0 mm	10.0, 11.0, 12.0, 13.0 mm	12.0, 14.5, 14.6 mm
Post Height	9.0 mm	9.0 mm	9.0, 10.5mm
Gingival Height	1.0, 2.0, 3.0, 4.0 mm	1.0, 2.0, 3.0, 4.0 mm	1.5, 3.0 mm
Angulation	Straight	Straight	Straight
ConnectionInterface	External Hex, External Non-Hex	External Hex, External Non-Hex	Internal Hex
Material	Ti-6A1-4V ELI (ASTM F136-13)	CP Ti Grade 4 (ASTM F67-13)	Ti-6A1-4V ELI (ASTM F136-13)
SurfaceTreatment	Anodizing	Anodizing	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Milling Abutment is asuperstructure which is connected tothe fixtures using the AbutmentScrew. It replaces the functions of themissing teeth as a dental abutment.	The Milling Abutment is asuperstructure which is connected tothe fixtures using the AbutmentScrew. It replaces the functions of themissing teeth as a dental abutment.	The Milling Abutment is asuperstructure which is connected tothe fixtures using the AbutmentScrew. It replaces the functions of themissing teeth as a dental abutment.
	Substantial Equivalence Discussion
1. SimilaritiesThe subject device has the same characteristic for the followings compared to the reference device 1.Indication for use, Design, Total Length, Post Height, Gingival Height, Angulation, Connection Interface, SurfaceTreatment, Single Use, Sterilization and Principle of Operation
2. DifferencesThe subject device has the different characteristic for the followings compared to the reference device 1.Diameter- The diameter of subject device is slightly different with reference device 1, but all the diameters of subject device lie
within combined range of reference devices.- MaterialThe subject device is made of titanium alloy while the reference device 1 is made entirely of commercially puretitanium, but has made with same material with reference device 2. Also, the multiple predicate & reference devicesfor titanium alloy are presented in the other component comparison charts.
3. DiscussionThe proposed Milling Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been- FDA cleared. Therefore, the proposed Milling Abutment and reference device 1 have common in Indication for use,Design, Total Length, Post Height, Gingival Height, Angulation, Connection Interface, Surface Treatment, Single Use,Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.

{21}------------------------------------------------

Gold Abutment

	Subject Device	Reference Device
510(k) No.	K203554	K052369
Device Name(CompatibleImplant System)	Gold AbutmentFor AnyOne External Implant System	UCLA Gold AbutmentFor ExFeel Dental Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne External Implant System is intended tobe surgically placed in the maxillary or mandibularmolar areas for the purpose providing prostheticsupport for dental restorations (Crown, bridges,and overdentures) in partially or fully edentulousindividuals. It is used to restore a patient's chewingfunction. Smaller implants (less than 6.0 mm) arededicated for immediate loading when goodprimary stability is achieved and with appropriateocclusal loading. Larger implants are dedicated forthe molar region and are indicated for delayedloading.	The ExFeel Dental Implant Systems are intended to beplaced in the upper or lower jaw to support prostheticdevices, such as artificial teeth, and to restore a patient'schewing function. This may be accomplished using eithera two stage surgical procedure or a single stage surgicalprocedure.
Design	Image: Design	Image: Design
Diameter (Ø)	4.0, 4.5, 5.5 mm	4.0, 4.5, 5.5 mm
Total Length	11.0, 11.2 mm	11.0, 11.2 mm
Post Height	10.0 mm	10.0 mm
Gingival Height	1.0, 1.2 mm	1.0, 1.2 mm
Angulation	Straight	Straight
Connection	External Hex,	External Hex,
Interface	External Non-Hex	External Non-Hex
Material	Body: Gold AlloySleeve: POM	Body: Gold AlloySleeve: POM
SurfaceTreatment	N/A	N/A
Single Use	Yes	Yes
Sterilization	Non-sterile	Non-sterile
Principle ofOperation	The Gold Abutment is connected to the fixtureusing the Abutment Screw and used for fabricationof abutment for either screw or cement retainedrestorations by casting gold alloy.	The UCLA Gold Abutment is connected to thefixture and used for fabrication of abutment foreither screw or cement retained restorations bycasting gold alloy.
Substantial Equivalence Discussion

1. Similarities

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

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

2. Differences

N/A -

1. Discussion
  -The proposed Gold Abutment had been FDA cleared under K052639 with product name of 'UCLA Gold Abutment', but it is being submitted to change their identifier with modification of product name only. Therefore, the proposed Gold Abutment and reference device have common in all the items in the comparison chart. Also, the fatigue testing is not considered since the proposed device is straight type.

{22}------------------------------------------------

Abutment Screw

	Subject Device	Reference Device 1	Reference Device 2
510(k) No.	K203554	K052369	K052369
Device Name(CompatibleImplant System)	Abutment ScrewFor AnyOne External Implant System	Coping ScrewFor ExFeel Dental Implant System	Temporary (Cylinder) ScrewFor ExFeel Dental Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne External ImplantSystem is intended to besurgically placed in the maxillaryor mandibular molar areas forthe purpose providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction. Smaller implants (lessthan 6.0 mm) are dedicated forimmediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar regionand are indicated for delayedloading.	The ExFeel Dental Implant Systemsare intended to be placed in theupper or lower jaw to supportprosthetic devices, such as artificialteeth, and to restore a patient'schewing function. This may beaccomplished using either a twostage surgical procedure or a singlestage surgical procedure.	The ExFeel Dental Implant Systemsare intended to be placed in theupper or lower jaw to supportprosthetic devices, such as artificialteeth, and to restore a patient'schewing function. This may beaccomplished using either a twostage surgical procedure or a singlestage surgical procedure.
Design	Image: Abutment Screw Design	Image: Coping Screw Design	Image: Temporary (Cylinder) Screw Design
Diameter (Ø)	2.45, 2.5 mm	2.5 mm	2.45 mm
Total Length	4.8, 7.5 mm	7.5 mm	4.8 mm
ConnectionInterface	Internal Conical Connection	Internal Conical Connection	Internal Conical Connection
Material	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6A1-4V ELI(ASTM F136-13)
SurfaceTreatment	Machined	Machined	Machined
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Abutment Screw is used forconnecting Fixture to Abutmentor Abutment to Cylinder.	The Coping Screw is used forconnecting Fixture to Abutment.	The Temporary (Cylinder) Screwis used for connecting Abutmentto Cylinder.
Substantial Equivalence Discussion
	Subject Device	Reference Device
510(k) No.	K203554	K052369
Device Name(CompatibleImplant System)	Regular AbutmentFor AnyOne External Implant System	Regular AbutmentFor ExFeel Dental Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne External Implant System isintended to be surgically placed in the maxillaryor mandibular molar areas for the purposeproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function. Smaller implants (less than6.0 mm) are dedicated for immediate loadingwhen good primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molar region andare indicated for delayed loading.	The ExFeel Dental Implant Systems are intended to be placedin the upper or lower jaw to support prosthetic devices, suchas artificial teeth, and to restore a patient's chewing function.This may be accomplished using either a two stage surgicalprocedure or a single stage surgical procedure.
Design	Image: Subject Device Design	Image: Reference Device Design
Diameter (Ø)	4.5, 4.8 mm	4.5, 4.8 mm
Total Length	3.0, 3.8, 4.0, 4.8, 5.5, 5.8, 7.0, 8.5 mm	3.0, 3.8, 4.0, 4.8, 5.5, 5.8, 7.0, 8.5 mm
Post Height	1.8 mm	1.8 mm
Gingival Height	1.2, 2.0, 3.0, 4.0 mm	1.2, 2.0, 3.0, 4.0 mm
Angulation	Straight	Straight
ConnectionInterface	External Hex,External Non-Hex	External Hex,External Non-Hex
Material	Ti-6A1-4V ELI(ASTM F136-13)	CP Ti Grade 3(ASTM F67-13)
SurfaceTreatment	Machined	Machined
Single Use	Yes	Yes
Sterilization	Non-sterile	Non-sterile
Principle ofOperation	The Regular Abutment is a pre-manufacturedprosthetic component connected to theendosseous dental implant using the RegularAbutment Screw for aid in prostheticrehabilitation.	The Regular Abutment is a pre-manufactured prostheticcomponent connected to the endosseous dentalimplant using the Regular Abutment Screw for aid inprosthetic rehabilitation.
Substantial Equivalence Discussion
1. SimilaritiesThe subject device has the same characteristic for the followings compared to the reference device.- Indication for use, Design, Diameter, Total Length, Post Height, Gingival Height, Angulation, Connection Interface,Surface Treatment, Single Use, Sterilization and Principle of Operation.
2. Differences- MaterialThe subject device is made of titanium alloy while the reference device is made entirely of commercially puretitanium, the leveraged materials are being used for similar devices and intended uses.
3. Discussion
	Subject Device	Reference Device
510(k) No.	K203554	K052369
Device Name(CompatibleImplant System)	Regular Abutment ScrewFor AnyOne External Implant System	Regular Abutment ScrewFor ExFeel Dental Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne External Implant System is intended tobe surgically placed in the maxillary or mandibularmolar areas for the purpose providing prostheticsupport for dental restorations (Crown, bridges,and overdentures) in partially or fully edentulousindividuals. It is used to restore a patient's chewingfunction. Smaller implants (less than 6.0 mm) arededicated for immediate loading when goodprimary stability is achieved and with appropriateocclusal loading. Larger implants are dedicated forthe molar region and are indicated for delayedloading.	The ExFeel Dental Implant Systems are intended to beplaced in the upper or lower jaw to support prostheticdevices, such as artificial teeth, and to restore a patient'schewing function. This may be accomplished using eithera two stage surgical procedure or a single stage surgicalprocedure.
Design
Diameter (Ø)	2.95, 3.5 mm	2.95, 3.5 mm
Total Length	7.9, 8.85, 9.05, 9.85, 10.55, 10.85, 11.85, 12.05,13.55 mm	7.9, 8.85, 9.05, 9.85, 10.55, 10.85, 11.85, 12.05,13.55 mm
ConnectionInterface	Internal Conical Connection	Internal Conical Connection
Material	Ti-6A1-4V ELI(ASTM F136-13)	CP Ti Grade 3(ASTM F67-13)
SurfaceTreatment	Machined	Machined
Single Use	Yes	Yes
Sterilization	Non-sterile	Non-sterile
Principle ofOperation	The Regular Abutment Screw is used for connectingFixture to Regular Abutment.	The Regular Abutment Screw is used for connectingFixture to Regular Abutment.
Substantial Equivalence Discussion

1. Similarities

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

Indication for use, Design, Diameter, Total Length, Connection Interface, Material, Surface Treatment, Single Use, -Sterilization and Principle of Operation.

Differences 2.

N/A -

3. Discussion

The proposed Abutment Screw had been FDA cleared under K052639 with product name of 'Coping Screw' and י 'Temporary (Cylinder) Screw', but it is being submitted to change their identifier with modification of product name only. Therefore, the proposed Abutment Screw and reference devices have common in all the items in the comparison chart.

{23}------------------------------------------------

Regular Abutment

The proposed Regular Abutment had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of material only. Therefore, the proposed Regular Abutment and reference device have common in all the items except the material difference is explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type.

{24}------------------------------------------------

Regular Abutment Screw

1. Similarities

The subject device has the same characteristic for the followings compared to the reference device.
Indication for use, Design, Diameter, Total Length, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation.

Differences 2.

Material -
The subject device is made of titanium alloy while the reference device is made entirely of commercially pure titanium, the leveraged materials are being used for similar devices and intended uses.

ന് Discussion

The proposed Regular Abutment Screw had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of material only. Therefore, the proposed Regular Abutment Screw and reference device have common in all the items except the material difference is explained not affecting on the substantial equivalence.

{25}------------------------------------------------

Multi-unit Abutment

	Subject Device	Reference Device 1	Reference Device 2	Reference Device 3
510(k) No.	K203554	K052369	K160670	K123988
Device Name(CompatibleImplant System)	Multi-unit AbutmentFor AnyOne ExternalImplant System	Regular AbutmentFor ExFeel Dental ImplantSystem	Esthetic-low AbutmentFor ET US SS ProstheticSystem	Multi-unit AbutmentFor AnyOne Internal ImplantSystem
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	OSSTEM Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne ExternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 6.0 mm)are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for the molarregion and are indicated fordelayed loading.	The ExFeel Dental ImplantSystems are intended to beplaced in the upper orlower jaw to supportprosthetic devices, such asartificial teeth, and torestore a patient's chewingfunction. This may beaccomplished using either atwo stage surgicalprocedure or a single stagesurgical procedure.	ET SystemThe HIOSSEN Prostheticsystem is intended for usewith a dental implant toprovide support forprosthetic restorationssuch as crowns, bridges, orover-dentures.US/ SS SystemThe OSSTEM Prostheticsystem is intended for usewith a dental implant toprovide support forprosthetic restorationssuch as crowns, bridges, orover-dentures.	The AnyOne InternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 6.0 mm)are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for the molarregion and are indicated fordelayed loading.
Design
Diameter (Ø)	4.8 mm	4.5, 4.8 mm	4.8, 5.5 mm	5.0 mm
Total Length	2.0, 3.0, 4.0, 5.0, 6.0mm	3.0, 3.8, 4.0, 4.8, 5.5,5.8, 7.0, 8.5 mm	2.1, 2.2, 3.0, 3.1, 4.0,4.1, 5.0, 5.1 mm	6.2, 7.2, 8.2, 9.2, 10.2mm
Post Height	1.0 mm	1.8 mm	Not Known	1.8 mm
Gingival Height	1.0, 2.0, 3.0, 4.0, 5.0mm	1.2, 2.0, 3.0, 4.0 mm	Not Known	1.5, 2.5, 3.5, 4.5, 5.5mm
Angulation	Straight	Straight	Straight	Straight
ConnectionInterface	External Non-Hex	External Hex,External Non-Hex	External Hex	Internal Hex,Internal Non-Hex
Material	Ti-6A1-4V ELI(ASTM F136-13)	CP Ti Grade 3(ASTM F67-13)	Titanium(ASTM F67)	Ti-6A1-4V ELI(ASTM F136-13)
SurfaceTreatment	Anodizing	Machined	Not Known	Anodizing
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Multi-unitAbutment is a pre-manufacturedprosthetic componentconnected to theendosseous dentalimplant using the Multi-unit Abutment Screw foraid in prostheticrehabilitation.	The Regular Abutment isa pre-manufacturedprosthetic componentconnected to theendosseous dentalimplant using theRegular AbutmentScrew for aid inprosthetic rehabilitation.	The Esthetic-lowAbutment is a pre-manufacturedprosthetic componentconnected to theendosseous dentalimplant using theEsthetic-low AbutmentScrew for aid inprosthetic rehabilitation.	The Multi-unitAbutment is a pre-manufacturedprosthetic componentconnected to theendosseous dentalimplant using the Multi-unit Abutment Screw foraid in prostheticrehabilitation.
Substantial Equivalence Discussion

Similarities

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

Indication for use, Design, Diameter, Angulation Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation.

Differences

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

{26}------------------------------------------------

Total Length, Post Height, Gingival Height

Almost all the lengths of subject device lie within combined range of reference device 1 & 2. The only difference is that slight shorter length(2.0mm) is added in the subject device but it is a very slight difference(0.1mm) between the shortest length(2.1mm) of reference device2.

The Post Height and Gingival Height are slightly different with reference devices, but but these do not cause a matter in substantial equivalence since the size difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.

Material -

Discussion 3.

The proposed Multi-unit Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared as with refence device 3. It has a different connection interface, but the reference device 1 and reference device 2 have same structure and characteristics with subject device. The proposed Multi-unit Abutment and reference device 1 have common in Indication for use, Design, Diameter, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since is straight type.

{27}------------------------------------------------

Multi-unit Angled Abutment

	Subject Device	Reference Device 1	Reference Device 2
510(k) No.	K203554	K182448	K052369
Device Name(CompatibleImplant System)	Multi-unit Angled AbutmentFor AnyOne External Implant System	Multi-unit Angled AbutmentFor AnyRidge Octa 1 Implant System	Regular AbutmentFor ExFeel Dental Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne External Implant Systemis intended 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 function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading.	The AnyRidge Octa 1 Implant Systemis intended to be surgically placed inthe maxillary or mandibular arches forthe purpose of 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. Largerimplants are dedicated for the molarregion.	The ExFeel Dental Implant Systemsare intended to be placed in the upperor lower jaw to support prostheticdevices, such as artificial teeth, and torestore a patient's chewing function.This may be accomplished usingeither a two stage surgical procedureor a single stage surgical procedure.
Design
Diameter (Ø)	4.8 mm	4.8 mm	4.5, 4.8 mm
Total Length	3.65, 4.65, 5.13, 5.65, 6.13 mm	6.8, 7.48, 7.8, 8.48, 8.5, 8.8, 8.98,9.5, 9.98, 10.5 mm	3.0, 3.8, 4.0, 4.8, 5.5, 5.8, 7.0, 8.5mm
Post Height	2.2 mm	2.2 mm	1.8 mm
Gingival Height	2.0, 3.0, 4.0, 5.0 mm	2.3, 3.3, 4.3mm	1.2, 2.0, 3.0, 4.0 mm
Angulation	17°, 30°	17°, 30°	Straight
ConnectionInterface	External Hex, External Non-Hex	Internal Octa, Internal Non-Octa	External Hex, External Non-Hex
Material	Ti-6A1-4V ELI (ASTM F136-13)	Ti-6A1-4V ELI (ASTM F136-13)	CP Ti Grade 3 (ASTM F67-13)
SurfaceTreatment	Anodizing	Anodizing	Machined
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Multi-unit Angled Abutment is apre-manufactured prostheticcomponent connected to theendosseous dental implant using theMulti-unit Abutment Screw for aid inprosthetic rehabilitation.	The Multi-unit Angled Abutment is apre-manufactured prostheticcomponent connected to theendosseous dental implant using theMulti-unit Abutment screw for aid inprosthetic rehabilitation.	The Regular Abutment is a pre-manufactured prosthetic componentconnected to the endosseous dentalimplant using the Regular AbutmentScrew for aid in prostheticrehabilitation.
Substantial Equivalence Discussion
1. SimilaritiesThe subject device has the same characteristic for the followings compared to the reference device 1.Indication for use, Design, Diameter, Post Height, Angulation, Material, Surface Treatment, Single Use, Sterilization- and Principle of Operation
2. DifferencesThe subject device has the different characteristic for the followings compared to the reference device 1.Total Length, Gingival HeightThe Total Length of subject device is slightly shorter than reference device 1, but it is due to the connection differenceand all the lengths lie within range of reference device 2. The Gingival Height of subject device is slightly differentwith reference device 1,, it does not cause a matter in substantial equivalence since the size difference is very minor,and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.
	Subject Device	Reference Device 1	Reference Device 2
510(k) No.	K203554	K123988	K182448
Device Name(CompatibleImplant System)	Multi-unit Abutment ScrewFor AnyOne External Implant System	Multi-unit Abutment ScrewFor AnyOne Internal Implant System	Multi-unit Abutment ScrewFor AnyRidge Octa 1 Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne External Implant Systemis intended 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 function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading.	The AnyOne Internal Implant Systemis intended 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 function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading.	The AnyRidge Octa 1 Implant Systemis intended to be surgically placed inthe maxillary or mandibular archesfor the purpose of 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. Largerimplants are dedicated for the molarregion.
Design	Image: Design of subject device	Image: Design of reference device 1	Image: Design of reference device 2
Diameter (Ø)	2.4, 2.9 mm	2.95 mm	2.1 mm
Total Length	6.7, 6.8, 7.7, 8.7, 9.7, 10.7 mm	11.5, 12.5, 13.5, 14.5, 15.5 mm	7.0 mm
ConnectionInterface	Internal Conical Connection	Internal Conical Connection	Internal Conical Connection
Material	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6A1-4V ELI(ASTM F136-13)
SurfaceTreatment	Anodizing, Machined	Machined	Machined
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Multi-unit Abutment Screw isused for connecting Multi-unitAbutment or Multi-unit AngledAbutment to the fixture.	The Multi-unit Abutment Screw isused for connecting Multi-unitAbutment to the fixture.	The Multi-unit Abutment Screw isused for connecting Multi-unitAbutment or Multi-unit AngledAbutment to the fixture.
Substantial Equivalence Discussion
Healing Cap
	Subject Device	Reference Device 1	Reference Device 2	Reference Device 3
510(k) No.	K203554	K052369	K123988	K171142
Device Name(CompatibleImplant System)	Healing CapFor AnyOne External ImplantSystem	Healing CapFor ExFeel Dental ImplantSystem	Octa Healing CapFor AnyOne InternalImplant System	Healing Cap Multi-UnitTitanium
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	Nobel Biocare USA LLC
Indications forUseStatement	The AnyOne ExternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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.	The ExFeel Dental ImplantSystems are intended to beplaced in the upper orlower jaw to supportprosthetic devices, such asartificial teeth, and torestore a patient's chewingfunction. This may beaccomplished using either atwo stage surgicalprocedure or a single stagesurgical procedure.	The AnyOne InternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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.	The Healing Cap Multi-unitTitanium is apremanufacturedprosthetic component to bedirectly connected to thedental abutment duringsoft tissue healing toprotect the internalconnection of theabutments and prepare thesoft tissue for theprosthetic procedure.Maximum intra-oral use is180-days.
Design
Diameter (Ø)	4.9, 5.0, 6.8 mm	4.8, 5.0 mm	4.0, 5.0, 5.2, 6.0 mm	5.0, 6.0, 6.9 mm
Total Length	4.2, 6.1 mm	4.4, 6.1 mm	3.65, 3.7, 3.75, 6.1 mm	4.1, 5.5 mm
ConnectionInterface	One-piece(with integrated screw)Two-piece(with titanium alloy screw)	One-piece(with integrated screw)	One-piece(with integrated screw)Two-piece(with titanium alloyscrew)	One-piece Healing Cap(with integrated screw)
Material	Ti-6A1-4V ELI(ASTM F136-13)	CP Ti Grade 3(ASTM F67-13)	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6A1-4V ELI(ASTM F136-13)
SurfaceTreatment	Machined	Machined	Machined	Not Known
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Sterile (Gamma)
Principle ofOperation	The Healing Cap is used forprotecting RegularAbutment or Multi-unit(Angled) Abutment andminimizing irritation totongue and oral mucosaduring period of gingivalhealing. It is connected tothe Abutment using itsthreaded part or CylinderScrew	The Healing Cap is used forprotecting Abutment andminimizing irritation totongue and oral mucosaduring period of gingivalhealing. It is connected tothe Abutment using itsthreaded part.	The Octa Healing Cap isused for protectingAbutment and minimizingirritation to tongue and oralmucosa during period ofgingival healing. It isconnected to the Abutmentusing its threaded part orCylinder Screw	The Healing Cap Multi-unitTitanium is used forprotecting Multi-unitAbutment and minimizingirritation to tongue and oralmucosa during period ofgingival healing. It isconnected to the Abutmentusing its threaded part.
Substantial Equivalence Discussion
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device 1.
Indication for use, Design, Surface Treatment, Single Use, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference device 1.
Diameter, Total Length
The Diameter and Total Length of subject device is slightly different with reference device 1, but all the dimensions
lie within combined range of reference devices.
Connection Interface
The subject device has one-piece and two-piece types both while the reference device 1 has one-piece type only, but
the reference device 2 has same connection interface as subject device.
Material
The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure
titanium, but has made with same material with reference device 2 & 3. Also, the leveraged materials are being used
for similar devices and intended uses.

-Connection Interface

The subject device has External Hex connection while the reference device 1 has Internal Hex connection, but has same connection structure as reference device 2. Also, the leveraged materials are being used for similar devices and intended uses.

ന് Discussion

The proposed Multi-unit Angled Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared as with reference device 1. It has a different connection interface, but the reference device 2 has same structure, intended use and characteristics with subject device. The differences are explained not affecting on the substantial equivalence, but the fatigue test was performed on the subject device 1 to confirm the substantial equivalence under the consideration of worst case in accordance with 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. The test result supports that the subject device is substantially equivalent to the reference device 1 and the differences are not affecting the substantial equivalence.

{28}------------------------------------------------

Multi-unit Abutment Screw

1. Similarities

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

Indication for use, Design, Connection Interface, Material, Single Use, Sterilization and Principle of Operation Differences

2.

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

Diameter -
The Diameter of subject device is slightly different with reference device 1, but and all the diameter lie within combined range of reference devices.

Discussion ന്

The proposed Multi-unit Abutment Screw is being submitted to add in Megagen's existing prosthetic portfolio which י had been FDA cleared. Therefore, the proposed Multi-unit Abutment Screw and reference device 1 have common in Indication for use, Design, Connection Interface, Material, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.

{29}------------------------------------------------

{30}------------------------------------------------

ന് Discussion

asses
One of proposed Healing Cap had been FDA cleared with K052639 and K123988, but it is being submitted to change -Healing Cap and reference device 1 have common Indication for use, Design, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.

{31}------------------------------------------------

Temporary Cylinder	Subject Device	Reference Device 1	Reference Device 2	Reference Device 3
510(k) No.	K203554	K123988	K182091	K182448
Device Name	Temporary CylinderFor AnyOne ExternalImplant System	Temporary CylinderFor AnyOne InternalImplant System	Esthetic-low TemporaryCylinderFor Osstem AbutmentSystem	Temporary AbutmentFor AnyRidge Octa 1Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	OSSTEM IMPLANT Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUseStatement	The AnyOne ExternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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.	The AnyOne InternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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.	Osstem Abutment Systemis intended for use with adental implant to providesupport forprostheticrestorationssuch as crowns, bridges, oroverdentures.	The AnyRidge Octa 1Implant System is intendedto be surgically placed inthe maxillary or mandibulararches for the purpose ofproviding 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 is achievedand with appropriateocclusal loading. Largerimplants are dedicated forthe molar region.
Design
Diameter (Ø)	4.8 mm	3.87, 4.8, 5.8 mm	4.8, 5.5 mm	4.0, 4.5, 5.0 mm
Total Length	12.0 mm	10.0 mm	12 mm	14.85, 15.85, 16.35,17.35 mm
Post Height	8.5 mm	7.0 mm	Not Known	10 mm
Gingival (Cuff)Height	3.0 mm	3.0 mm	Not Known	2.0, 3.0 mm
Angulation	Straight	Straight	Straight	Straight
ConnectionInterface	Non-Hex	Octa, Non-Octa	Hex	Internal Octa, InternalNon-Octa
Material	Ti-6A1-4V ELI(ASTM F136-13)	CP Ti Grade 4(ASTM F67-13)	Titanium Gr. 3(ASTM F67)	Ti-6A1-4V ELI(ASTM F136-13)
SurfaceTreatment	Machined	Machined	Not Known	Machined
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Temporary Cylinder isused in conjunction withMulti-unit Abutment orMulti-unit AngledAbutment to providesupport for provisionalrestoration. It is connectedto the Abutment usingCylinder Screw	The Temporary Cylinder isused in conjunction withAbutment to providesupport for provisionalrestoration. It is connectedto the Abutment usingCylinder Screw	The Esthetic-lowTemporary Cylinder is usedin conjunction with MultiAbutment, US Multi AngledAbutment or Esthetic-lowAbutment to providesupport for provisionalrestoration. It is connectedto the Abutment usingCylinder Screw	The Temporary Abutment isused in conjunction withFixture to provide supportfor provisional restoration.It is connected to Fixtureusing the Screw.

Total Length, Post Height -
The Total Length and Post Height of subject device is slightly different with reference device 1 but all the dimensions of subject device lie within combined range of reference devices.
-Connection Interface
The Connection Interface of subject device is different with reference device 1, but Non-Hex in the subject device and Non-Octa in predicate device are same structure without anti-rotation function which can be connected in any direction.

{32}------------------------------------------------

Material -

ന് Discussion

The proposed Temporary Cylinder is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed Temporary Cylinder and reference device 1 have common in Indication for use, Design, Diameter, Angulation, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type and temporarily used.

{33}------------------------------------------------

EZ Post Cylinder

	Subject Device	Reference Device 1	Reference Device 2
510(k) No.	K203554	K052369	K192347
Device Name(Compatible ImplantSystem)	EZ Post CylinderFor AnyOne External ImplantSystem	Conical AbutmentFor ExFeel Dental Implant System	EZ Post AbutmentFor ST Internal Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications for UseStatement	The AnyOne External ImplantSystem is intended to be surgicallyplaced in the maxillary ormandibular molar areas for thepurpose 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.	The ExFeel Dental Implant Systemsare intended to be placed in theupper or lower jaw to supportprosthetic devices, such as artificialteeth, and to restore a patient'schewing function. This may beaccomplished using either a twostage surgical procedure or a singlestage surgical procedure.	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: [EZ Post Cylinder design]	Image: [Conical Abutment design]	Image: [EZ Post Abutment design]
Diameter (Ø)	5.0 mm	5.0 mm	4.6, 5.0, 6.0, 7.0 mm
Total Length	8.5 mm	8.5 mm	7.5 - 14.5 mm
Post Height	7.7 mm	7.7 mm	4.0, 5.5, 7.0 mm
Gingival (Cuff)Height	0.8 mm	0.8 mm	1.0, 2.0, 3.0, 4.0, 5.0mm
Angulation	Straight	Straight	Straight
ConnectionInterface	Hex, Non-Hex	Hex, Non-Hex	Internal Hex,Internal Non-Hex
Material	Ti-6A1-4V ELI(ASTM F136-13)	CP Ti Grade 3(ASTM F67-13)	Ti-6A1-4V ELI(ASTM F136-13)
Surface Treatment	Machined	Machined	Anodizing
Single Use	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The EZ Post Cylinder is used inconjunction with RegularAbutment to provide supportfor cement and screw type finalprosthesis. It is connected to theAbutment using AbutmentScrew.	The Conical Abutment is used inconjunction with RegularAbutment to provide supportfor cement and screw type finalprosthesis. It is connected to theAbutment using AbutmentScrew.	The EZ Post Abutment is asuperstructure which isconnected to the fixtures usingthe Abutment Screw. It replacesthe functions of the missingteeth as a dental abutment.
Substantial Equivalence Discussion

Similarities 1.

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

Indication for use, Design, Diameter, Total Length, Post Height, Gingival (cuff) Height, Angulation, Connection -Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation.

Differences 2.

Material -

Discussion ന്

The proposed EZ Post Cylinder had been FDA cleared under K052639 with product name of 'Conical Abutment', but it is being submitted to change their with modification of product name and material. Therefore, the proposed EZ Post Cylinder and reference device 1 have common in Indication for use, Design, Diameter, Total Length, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The material difference is explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type.

{34}------------------------------------------------

Gold Cylinder

	Subject Device	Reference Device	CCM Cylinder	Subject Device	Reference Device 1	Reference Device 2	Reference Device 3
510(k) No.	K203554	K123988	510(k) No.	K203554	K123988	K182448	K123988
Device Name(CompatibleImplant System)	Gold CylinderFor AnyOne External Implant System	Gold CylinderFor AnyOne Internal Implant System	Device Name	CCM CylinderFor AnyOne ExternalImplant System	CCM CylinderFor AnyOne InternalImplant System	CCM AbutmentFor AnyRidge Octa 1Implant System	Gold CylinderFor AnyOne InternalImplant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	Manufacturer	MegaGen Implant Co.,Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne External Implant System is intended tobe surgically placed in the maxillary or mandibularmolar areas for the purpose providing prostheticsupport for dental restorations (Crown, bridges,and overdentures) in partially or fully edentulousindividuals. It is used to restore a patient's chewingfunction. Smaller implants (less than 6.0 mm) arededicated for immediate loading when goodprimary stability is achieved and with appropriateocclusal loading. Larger implants are dedicated forthe molar region and are indicated for delayedloading.	The AnyOne Internal Implant System is intended to besurgically placed in the maxillary or mandibular molarareas for the purpose providing prosthetic support fordental restorations (Crown, bridges, and overdentures) inpartially or fully edentulous individuals. It is used torestore a patient's chewing function. Smaller implants(less than 6.0 mm) are dedicated for immediate loadingwhen good primary stability is achieved and withappropriate occlusal loading. Larger implants arededicated for the molar region and are indicated fordelayed loading.	Indications forUseStatement	The AnyOne ExternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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.	The AnyOne InternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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.	The AnyRidge Octa 1Implant System is intendedto be surgically placed inthe maxillary or mandibulararches for the purpose ofproviding 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 is achievedand with appropriateocclusal loading. Largerimplants are dedicated forthe molar region.	The AnyOne InternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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: red cylinder	Image: red cylinder	Design
Diameter (Ø)	4.8 mm	4.0, 4.8, 5.1, 6.0 mm	Diameter (Ø)	4.8 mm	4.0, 5.1, 6.0 mm	3.8 mm	4.0, 4.8, 5.1, 6.0 mm
Total Length	13.0 mm	12.0, 13.0 mm	Total Length	13.0, 15.0 mm	12.0 mm	14.65, 16.15 mm	12.0, 13.0 mm
Post Height	10.0 mm	10.0 mm	Post Height	10.0, 13.0 mm	10.0 mm	11.6 mm	10.0 mm
Gingival (Cuff)Heights	3.0 mm	2.0, 3.0 mm	Gingival (Cuff)Heights	2.0, 3.0 mm	2.0 mm	1.0 mm	2.0, 3.0 mm
Angulation	Straight	Straight	Angulation	Straight	Straight	Straight	Straight
Connection	Hex, Non-Hex	Octa, Non-Octa	ConnectionInterface	Hex, Non-Hex	Octa, Non-Octa	Octa, Non-Octa	Octa, Non-OctaHex, Non-Hex
Interface	Hex, Non-Hex	Hex, Non-Hex	Material	Body: Co-Cr-Mo AlloySleeve: POM	Body: Co-Cr-Mo AlloySleeve: POM	Body: Co-Cr-Mo AlloySleeve: POM	Body: Gold AlloySleeve: POM
Material	Body: Gold AlloySleeve: POM	Body: Gold AlloySleeve: POM	SurfaceTreatment	N/A	N/A	N/A	N/A
SurfaceTreatment	N/A	N/A	Single Use	Yes	Yes	Yes	Yes
Single Use	Yes	Yes	Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Sterilization	Non-sterile	Non-sterile	Principle ofOperation	The CCM Cylinder is used inconjunction with RegularAbutment or Multi-unit(Angled) Abutment toprovide support for screwtype final prosthesis bycasting with non-preciousmetal alloy (CCM alloy). It isconnected to the Abutmentusing Abutment Screw orCylinder Screw.	The CCM Cylinder is used inconjunction with Abutmentto provide support forscrew type final prosthesisby casting with non-precious metal alloy (CCMalloy). It is connected to theAbutment using the Screw.	The CCM Abutment is usedin conjunction with Fixtureto provide support forscrew type final prosthesisby casting with non-precious metal alloy (CCMalloy). It is connected to theFixture using the Screw.	The Gold Cylinder is used inconjunction with Abutmentto provide support forscrew type final prosthesisby casting with gold alloy. Itis connected to theAbutment using the Screw.
Principle ofOperation	The Gold Cylinder is used in conjunction withRegular Abutment to provide support for screwtype final prosthesis by casting with precious metalalloy (Gold alloy). It is connected to the Abutmentusing Abutment Screw.	The Gold Cylinder is used in conjunction withAbutment to provide support for screw type finalprosthesis by casting with precious metal alloy(Gold alloy). It is connected to the Abutment usingthe Screw.
Substantial Equivalence Discussion

Similarities 1.

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

Indication for use, Design, Diameter, Total Length, Post Height, Angulation, Connection Interface, Material, Surface -Treatment, Single Use, Sterilization and Principle of Operation.

Differences 2.

N/A -
ന് Discussion
- The proposed Gold Cylinder had been FDA cleared with K123988, but it is being submitted to change their identifier only without any modification. Therefore, the proposed Gold Cylinder and reference device have common in all the items in the comparison chart. Also, the fatigue testing is not considered since the proposed device is straight type.

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1. Similarities

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

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

Differences

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

Diameter, Total Length, Post Height, Gingival (Cuff) Height י
The diameter, Total length and Gingival (cuff) Height of subject device is slightly different with reference device 1 but all the dimensions of subject device lie within range of reference devices. The subject device has same Post Height as predicate for P.H 10.0mm. The only difference is that slight (13.0mm) is added in the subject

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device, but the Total Length of subject device lie within combined range of reference devices. Also, these do not cause a matter in substantial equivalence since the size difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.

-Connection Interface

The subject device has Hex / Non-Hex connection while the reference device 1 has Octa / Non-Octa connection.
However, the connection difference can be covered by the referenc provides anti-rotational feature and multiple predicate & reference devices for Hex / Non-Hex are already presented in the other component comparison charts.

ന് Discussion

The proposed CCM Cylinder is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed CCM Cylinder and reference device 1 have common in Indication for use, Design, Angulation, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type.

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	Cylinder Screw
--	----------------	--	--	--

	Subject Device	Reference Device 1	Reference Device 2	Reference Device 3
510(k) No.	K203554	K052369	K053353	K123988
Device Name	Cylinder ScrewFor AnyOne ExternalImplant System	Cylinder ScrewFor ExFeel Dental ImplantSystem	Cylinder ScrewFor Rescue Dental ImplantSystem	Flat Cylinder ScrewFor AnyOne InternalImplant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUseStatement	The AnyOne ExternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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.	The ExFeel Dental ImplantSystems are intended to beplaced in the upper orlower jaw to supportprosthetic devices, such asartificial teeth, and torestore a patient'schewing function. This maybe accomplished usingeither a two stage surgicalprocedure or a single stagesurgical procedure.	The Rescue® 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.These implants areintended to be used wheresmaller implants havefailed.	The AnyOne InternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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: screw	Image: screw	Image: screw	Image: screw
Diameter (Ø)	2.0 mm	2.5 mm	2.9	2.1 mm
Total Length	3.4 mm	4.85 mm	4.2 mm	5.9 mm
ConnectionInterface	Internal ConicalConnection	Internal ConicalConnection	Internal ConicalConnection	Internal ConicalConnection
Material	Ti-6A1-4V ELI(ASTM F136-13)	CP Ti Grade 3(ASTM F67-13)	CP Ti Grade 3(ASTM F67-13)	Ti-6A1-4V ELI(ASTM F136-13)
SurfaceTreatment	Machined	Machined	Machined	Machined
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Cylinder Screw is usedfor connecting Multi-unit(Angled) Abutment toHealing Cap, TemporaryCylinder or CCM Cylinder.	The Cylinder Screw is usedfor connecting Abutment toHealing Cap or Cylinder.	The Cylinder Screw is usedfor connecting Abutment toHealing Cap or Cylinder.	The Flat Cylinder Screw isused for connectingAbutment to Healing Cap orCylinder.
Substantial Equivalence Discussion
1.	Similarities
	Subject Device	Reference Device 1	Reference Device 2	Reference Device 3
510(k) No.	K203554	K182448	K182091	K192614
Device Name(CompatibleImplant System)	Meg-Rhein AbutmentFor AnyOne ExternalImplant System	Meg-Rhein AbutmentFor AnyRidge Octa 1Implant System	Port AbutmentFor Osstem AbutmentSystem	Meg-Magnet AbutmentFor Meg-Ball AttachmentSystem, Meg-LocAbutment,Meg-Magnet Abutment
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	OSSTEM IMPLANT Co., Ltd.	MegaGen Implant Co., Ltd.
Indications forUse Statement	The AnyOne ExternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 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.	The AnyRidge Octa 1Implant System is intendedto be surgically placed inthe maxillary or mandibulararches for the purpose ofproviding 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 whengoodprimary stability is achievedand with appropriateocclusal loading. Largerimplants are dedicated forthe molar region.	Osstem Abutment Systemis intended for use with adental implant to providesupport forprosthetic restorationssuch as crowns, bridges, oroverdentures.	Meg-Ball AttachmentSystem, Meg-LocAbutment, Meg-MagnetAbutment is intended to beused in theupper or lower jaw andused for supporting toothreplacements to restorechewing function. Intendedfor fully edentulous jawretaining a tissue supportedoverdenture.The abutments incombination withendosseous implants areused as the foundation foranchoring toothreplacements in either jaw.The attachments are usedin fixed overdenturerestorations that can beattachedwith a snap-in system.
Design
HeadDiameter (Ø)	2.5 mm	2.5 mm	Not Known	N/A
Head Height(Post Height)	1.7 mm	1.7 mm	Not Known	N/A
Diameter (Ø)	3.5, 4.1, 5.0 mm	2.907, 3.407 mm	3.5, 3.7, 4.1, 4.8, 5.1mm	4.5, 5.0mm
Total Length	7.9, 9.9, 11.9 mm	8.3, 8.8, 9.8, 10.8, 11.8,12.8, 13.8 mm	Not Known	5.65 – 11.4 mm
GingivalHeight	2.0, 4.0, 6.0 mm	0.3, 0.8, 1.8, 2.8, 3.8,4.8, 5.8 mm	1.0, 2.0, 3.0, 4.0, 5.0,6.0, 7.0 mm	0.3, 0.8, 1.8, 2.8, 3.8,4.8, 5.8mm
Angulation	Straight	Straight	Straight	Straight
ConnectionInterface	Internal ConicalConnection	Internal ConicalConnection	Internal ConicalConnection	Internal ConicalConnection
Material	Ti-6A1-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)	Ti-6Al-4V ELI(ASTM F136-13)	Stainless Steel(ASTM F899-09)
SurfaceTreatment	Partial TiN coating	Machined	Partial TiN coating	Partial TiN coating
Single Use	Yes	Yes	Yes	Yes
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Principle ofOperation	The Meg-RheinAbutment is generallyapplied to prostheticprocedure foroverdentures. The headpart is where connectedto overdenture withattachment and thescrew part is connecteddirectly to theendosseous dentalimplant by theirthreaded part.	The Meg-RheinAbutment is generallyapplied to prostheticprocedure foroverdentures. The headpart is where connectedto overdenture withattachment and thescrew part is connecteddirectly to theendosseous dentalimplant by theirthreaded part.	The Port Abutment isgenerally applied toprosthetic procedure foroverdentures. The headpart is where connectedto overdenture withattachment and thescrew part is connecteddirectly to theendosseous dentalimplant by theirthreaded part.	The Meg-MagnetAbutment is generallyapplied to prostheticprocedure foroverdentures. The headpart is where connectedto overdenture withattachment and thescrew part is connecteddirectly to theendosseous dentalimplant by theirthreaded part.

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

Indication for use, Design, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of -Operation

Differences

The subject device has the different characteristic for the followings compared to the reference device 1.
Diameter, Total Length -
- The Diameter and Total Length of subject device is slightly different with reference devices but it does not cause a matter in substantial equivalence since the size difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.
-Material
- The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure titanium, but has made with same material with reference device 3. Also, the leveraged materials are being used for similar devices and intended uses.

ന് Discussion

The proposed Cylinder Screw is being submitted to add in Megagen's existing prosthetic portfolio which had been -FDA cleared. Therefore, the proposed Cylinder Screw and reference device 1 have common in Indication for use, Design, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.

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Meg-Rhein Abutment

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Substantial Equivalence Discussion
1.	Similarities
	The subject device has the same characteristic for the followings compared to the reference device 1.- Indication for use, Design, Head Diameter, Head Height (Post Height), Angulation, Connection Interface, Material, Single Use, Sterilization and Principle of Operation.
2.	Differences
	The subject device has the different characteristic for the followings compared to the reference device 1.- Diameter, Total Length, Gingival Height- The Diameter, Total Length and Gingival Height of subject device is slightly different with reference device 1 but all the dimensions of subject device lie within combined range of reference devices.- Surface Treatment- Surface Treatment- The subject device is treated with partial Tin Coating in upper part while the predicate device is not applicable, but has same surface treatment as reference device 2 and Megagen's FDA cleared reference device 3.
3.	Discussion
	The proposed Meg-Rhein Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared as with reference device 1. Therefore, the proposed Meg-Rhein Abutment and reference device 1 have common in Indication for use, Design, Head Diameter, Head Height (Post Height), Angulation, Connection Interface, Material, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the additional fatigue testing is not considered based on FDA Guidance Document being as proposed abutment is straight type. The subject abutment is intended for straight implantation, and is not received single load, because it used for supporting the overdenture that means load is dispersed to the full denture.

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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 AnyOne External Implant System since AnyOne External Implant System has same material composition, manufacturing process and patient contacting parts as predicate device, XPEED AnyRidge Internal Implant System (K122231) for the Fixture, and ST Internal Implant System (K192347), AnyOne Internal Implant System (K123988), AnyRidge Octa 1 Implant System (K182448) and Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K19614) for the Abutment.

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 Implant Abutment'.

AnyOne External Implant System has same surface treatment and manufacturing process as predicate device, XPEED AnyRidge Internal Implant System (K122231) for the surface treatment of S.L.A (Fixture), ST Internal Implant System(K192347) for the Anodizing method (Abutment), and Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K19614) for TiN coating (Abutment).

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

Sterilization validating testing has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (104). 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.

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

Performance (Physical Properties) 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.

י Static compression-strength test
. Fatigue test

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9. Summary of Clinical Testing

No clinical studies are submitted.

10. Conclusion

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

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.