EXFEEL IMPLANT SYSTEM

K052369 · Megagen Co., Ltd. · DZE · Jan 10, 2006 · Dental

Device Facts

• Record ID: K052369
• Device Name: EXFEEL IMPLANT SYSTEM
• Applicant: Megagen Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jan 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

ExFeel Implant System comprises endosseous rootform dental implants and associated abutments; designed to support prosthetic devices (artificial teeth) in partially or fully edentulous patients. Implants placed in upper or lower jaw via single or two-stage surgical procedures. System includes fixtures, protective caps, and surgery trays. Rough surface facilitates osseointegration; smooth titanium surface contacts mucosa. Clinician selects from screw-retained or cement-retained restoration options. Device restores patient chewing function. Used in clinical dental settings by licensed practitioners.

Clinical Evidence

Bench testing only. No clinical data provided. Functionality and design conformance verified through laboratory testing.

Technological Characteristics

Endosseous dental implants; materials: C.P. Titanium and Titanium Alloy; surface: rough (bone contact) and smooth (mucosa contact); connection types: internal, external hex, and Morse taper; diameters: 3.75–5.5 mm; lengths: 7.0–18.0 mm; sterilization: Gamma radiation; packaging: Class 10,000 clean room, Tyvek sealed.

Indications for Use

Indicated for partially or fully edentulous patients requiring prosthetic support in the mandible or maxilla; intended for use in single or two-stage surgical procedures to restore chewing function.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BIOPLANT Implant Systems (K041655)
• Branemark Systems (K925777, K925779, K961723, K971706)
• ITI Dental Implant (K002374)
• Nobel Biocare Branemark Dental Implant (K993595)

Submission Summary (Full Text)

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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: [phone], Fax: [phone]

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 : [phone]. Fax : [phone] |
| 13-2. US Agent /<br>Contact Person | Dae Kyu Chang |
| | 13340 E. Firestone Blvd. Suite J |
| | Santa Fe Springs, CA 90670 |
| | Phone : [phone], Fax : [phone] |
| 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 functionality<br>and conformance to design input requirements |

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. . . . . . . .

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#### 13-9. 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.

#### 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 Dental<br>Implant Systems | Nobel Biocare<br>K993595 | ITI Dental Implant<br>System K002374 |
|--------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Manufacturer | Megagen Co., Ltd. | Nobel Biocare USA | Institute Straumann<br>AG |
| Indications for Use | Mandible and<br>Maxilla Endosseous<br>Dental Implant &<br>Accessories | Mandible and<br>Maxilla Endosseous<br>Dental Implant &<br>Accessories | Mandible and<br>Maxilla Endosseous<br>Dental Implant &<br>Accessories |
| Design: | Internal, External<br>Hex and<br>Morse Taper | Internal, External<br>Hex and<br>Morse Taper | Internal, External<br>Hex and<br>Morse Taper |
| Endosseous<br>Implant Material | C.P Titanium and<br>Titanium Alloy | C.P Titanium and<br>Titanium Alloy | C.P Titanium and<br>Titanium 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 abutments<br>and 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 [phone]. 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 [phone] or [phone] 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:

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

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

OR

| 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