The ExFeel Dental Implant Systems are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure

Device Description

The ExFeel® Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. ExFeel® implant Fixture Systems consist of one-stage, rootform dental implants, associated with abutment systems, which provide the clinician with screw and cement retained restoration for multi-mount, screw retained restoration for octa abutment, and cement retained restoration for solid abutment restorative options. The devices covered by this submission are ExFeel® Implant Fixtures, Retained Restoration Abutment System.

AI/ML Overview

The provided text is a 510(k) summary for the "ExFeel® IMPLANT SYSTEMS." It details the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical or analytical validation with human subjects or AI algorithms.

Instead, this document focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) based on design, materials, intended use, and laboratory testing for functionality and conformance to design input requirements. This is a common approach for medical devices cleared through the 510(k) pathway, where a direct comparison to a predicate device often fulfills the regulatory requirement for demonstrating safety and effectiveness without requiring extensive new clinical trials.

Therefore, I cannot provide the requested information because it is not present in the given text. The text explicitly states:

"13-8. Performance Laboratory testing was conducted to determine device functionality and conformance to design input requirements" - This indicates engineering/bench testing, not clinical performance acceptance criteria against human data or AI performance.
"13-12. Basis for Substantial Equivalence The Exfeel Implants are substantially to ITI Dental Implant(K002374), Nobel Biocare Branemark Dental Implant(K993595) in intended use, material and design." - This highlights the primary method of demonstrating safety and effectiveness.

To explicitly answer your request based on the provided text:

A table of acceptance criteria and the reported device performance: Not available. The document refers to "laboratory testing... to determine device functionality and conformance to design input requirements," but it does not specify what those criteria were or detail the results in a performance table.
Sample size used for the test set and the data provenance: Not applicable, as there is no human test set or data described. The "test set" here would refer to the physical implants subjected to laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical or image-based AI studies is not relevant to this type of submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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052369/41

13. 510(K) SUMMARY

JAN 1 0 2006

Mega'Gen Co., Ltd. 114-8. Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone: 82-53-857-5770, Fax: 82-53-857-5432

510(K) Summary

510(K) SUMMARY AND CERTIFICATION
This summary of 510(K) safety and effectiveness information is being submitted in
accordance with the requirements of 21 CFR & 807.93
13-1. Submitter	Mega'Gen Co., Ltd.
	114-8, Eupchun-Ri, Jain-Myun,
	Gyeongsan, Gyeongbuk
	South Korea
	Phone : 82-53-857-5770. Fax : 82-53-857-5432
13-2. US Agent /Contact Person	Dae Kyu Chang
	13340 E. Firestone Blvd. Suite J
	Santa Fe Springs, CA 90670
	Phone : 562-404-8466, Fax : 562-404-2757
13-3. Date Prepared	August 20, 2005
13-4. Device Name	EXFEEL® IMPLANT SYSTEMS
	ExFeel® Internal and External Fixtures
	ExFeel® Internal and External Retained Restoration Abutments
13-5. Classification Name	Endosseous Dental Implant System
13-6. Device Classification	Class II
	Dental Devices panel
	21 CFR § 872.3640
	Regulation Number: 872.3640
13-7. Predicate Devices	BIOPLANT Implant Systems (K041655) &
	Branemark Systems (K925777, K925779, K961723, K971706)
13-8. Performance	Laboratory testing was conducted to determine device functionalityand conformance to design input requirements

y34

. . . . . . . .

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13-9. Device Description

13-10. Packing / Labeling / Product Information

In a clean room that is Class 10,000 or less, put the product into a capsule, and then put the capsule in a pet container, which is 45mm by 75mm, then sealed the pet container with PERFECSEAL CR27 1073B Coated Tyvek®. ExFeel™ Implant Systems (ExFeel ™ Implant Fixtures, ExFeel Protective Cap, and ExFeel Implant System Surgery Tray) will be packaged.

13-11. Intended Use

The ExFee! Dental Implant Systems are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure

13-12. Basis for Substantial Equivalence

The Exfeel Implants are substantially to ITI Dental Implant(K002374), Nobel Biocare Branemark Dental Implant(K993595) in intended use, material and design. The Exfeel Implants are composed of the same material and have the same surface as the cleared ITI, Nobel Biocare dental implants. In addition, the design of the Exfeel implants is similar to the predicate implants. The Dental implants has the rough surface in contact with bone for osseointegration and a smooth titanium surface in contact with mucosa. The design of the Exfeel implants are similar to the commercially available Nobel Biocare Branemark and Implant Innovations implants.

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13-13. Comparative Data

The Following table provides a comparison of the technological characteristics of the predicate devices, Nobel Biocare and ITI Dental Implant

Comparison Between the ExFeel® Implant System, Nobel Biocare's modified surface Implant, and ITI Dental Implant System Monotype Implant.

Characteristic	ExFeel DentalImplant Systems	Nobel BiocareK993595	ITI Dental ImplantSystem K002374
Manufacturer	Megagen Co., Ltd.	Nobel Biocare USA	Institute StraumannAG
Indications for Use	Mandible andMaxilla EndosseousDental Implant &Accessories	Mandible andMaxilla EndosseousDental Implant &Accessories	Mandible andMaxilla EndosseousDental Implant &Accessories
Design:	Internal, ExternalHex andMorse Taper	Internal, ExternalHex andMorse Taper	Internal, ExternalHex andMorse Taper
EndosseousImplant Material	C.P Titanium andTitanium Alloy	C.P Titanium andTitanium Alloy	C.P Titanium andTitanium Alloy
Implant Sterile	Yes	Same	Same
Sterilization Method	Gamma	Gamma	Gamma
Implant Diameters	3.75 – 5.5 mm	Equivalent	Equivalent
Implant Lengths	7.0 – 18.0 mm	Equivalent	Equivalent
Attachments	Various abutmentsand components	Equivalent	Equivalent
Product Code	DZE & NHA	Same	Same

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the perimeter. In the center of the seal is a stylized image of an eagle, which is a common symbol of the United States government.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2006

Mega' Gen Company Limited C/O Mr. Dae Kyu Chang President Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K052369

Trade/Device Name: ExFeel Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: December 1, 2005 Received: December 27, 2005

Dear Mr. Chang:

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 Mcdical 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. 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.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Chang

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin. Ph.D Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(K) Number (if known): __ Ko ≤ Z 369

ExFeel Dental Implant System Device Name:

Indications For Use:

Prescription Use	_____________________________________________________________________________________________________________________________________________________________
(Part 2) CFR 801 Subpart D)

Over - The Counter Use
(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Runner

al Hospital

510(k) K052861

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.