ALLFIM IMPLANT SYSTEMS

K050635 · Cowellmedi Co., Ltd. · DZE · Jul 28, 2005 · Dental

Device Facts

• Record ID: K050635
• Device Name: ALLFIM IMPLANT SYSTEMS
• Applicant: Cowellmedi Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jul 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options. The devices covered by this submission are Atlas Fixtures, and Atlas Shoulder Abutments which are placed into dental implant to provide support for prosthetic reconstruction. The non-hexa-shoulder abutment is designed for single crown use only. The hexa-shoulder abutment is designed for bridge use only

Device Story

Allfim Implant System consists of two-stage, root-form dental implants (Atlas Fixtures) and associated abutment systems (Atlas Shoulder Abutments). Implants are surgically placed into the maxilla or mandible to achieve osseointegration. System provides restorative options including cement-retained, screw-retained, and overdenture restorations. Non-hexa-shoulder abutments are for single crowns; hexa-shoulder abutments are for bridges. Used by dental clinicians in clinical settings to restore patient chewing function. Output is a stable foundation for prosthetic attachments. Benefits include restoration of oral function for edentulous patients.

Clinical Evidence

Bench testing only. Laboratory testing conducted to determine device functionality and conformance to design input requirements.

Technological Characteristics

Root-form endosseous dental implants and abutments. Material: Titanium. Surface: Roughened. Design: Threaded, two-stage. Dimensions: Various diameters (3.3mm, 4.0mm, 5.0mm) and collar heights. Connectivity: Mechanical interface for prosthetic attachment.

Indications for Use

Indicated for partially or fully edentulous patients requiring dental implant surgery for prosthetic reconstruction, including single or multiple-unit restorations (cement-retained, screw-retained, or overdenture) and fixed bridgework support.

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)
• Branemark Systems (K925779)
• Branemark Systems (K961728)
• Branemark Systems (K971706)

Submission Summary (Full Text)

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K050635

# JUL 2 8 2005

## 10. 510(K) SUMMARY

Cowell Medi Co., Ltd Dong-Ju Bldg 2F 45-3 Gaya 1 Dong, Busanjin-Gu, 614-800 Busan city, South Korea Phone : [phone] Fax

## 510(K) Summary

## 510(K) SUMMARY AND CERTIFICATION

This summary of 510(K) Safety and effectiveness information is being submitted in
This summary of 510(K) safety and effectiveness information is being submitted in
this summa accordance with the requirements of 21 CFR & 807.93

| 10-1. Submitter | Cowell Medi Co., Ltd.<br>Dong-Ju Bldg 2F 45-3<br>Gaya 1 Dong, Busanjin-Gu 614-800<br>Busan, South Korea |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| | Phone : [phone], Fax : [phone] |
| 10-2. US Agent /<br>Contact Person | Dae Kyu Chang<br>13340 E. Firestone Blvd. Suites J<br>Santa Fe Springs, CA 90670<br>Phone : [phone], Fax : [phone] |
| 10-3. Date Prepared | March 5, 2005 |
| 10-4. Device Name | ALLFIM IMPLANT SYSTEMS<br>Atlas Fixtures and Atlas Shoulder Abutment Systems |
| 10-5. Classification Name | Endosseous Dental Implant System |
| 10-6. Device Classification | Class II<br>Dental Devices panel<br>21 CFR § 872.3640<br>Regulation Number: 872.3640 |
| 10-7. Predicate Devices | BIOPLANT Implant Systems (K041655) &<br>Branemark Systems (K925777, K925779, K961728, K971706) |
| 10-8. Performance | Laboratory testing was conducted to determine device<br>functionality and conformance to design input requirements. |

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### 10-9. Device Description

Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous which dostyled in the more and Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options. The devices covered by this submission are Atlas Fixtures, and Atlas Shoulder Abutments which are placed into dental implant to provide support for prosthetic reconstruction.

### 10-10. Packing / Labeling / Product Information /

Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutment Systems) will be packaged.

#### 10-11. Intended Use

Allfim Implant Systems refer to sets of root form endosseous dental implants and compatible implant abutment systems. Allfim Implant Systems are designed for use in dental implant surgery and are intended to be used in a manor in which they (the implants) integrate with the bone (osseointegration). The Allfim Abutment Systems include various abutments designed to enable the implant process from healing thru final restoration. The Atlas Fixtures are part of the Allfim Implant Systems and they are intended to use for two-stage surgical procedures. They are used on upper and lower jaw to provide a means for prosthetic attachments to restore a patient's chewing function. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including, cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

### 10-12. Substantial Equivalence Comparison

Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutment Systems) and predicate implants share a substantially equivalent intended use. The

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Image /page/2/Picture/0 description: The image shows a handwritten text string that appears to be a code or identifier. The text reads 'K050635', with each character written in a distinct, slightly irregular style. The numbers are clearly distinguishable, and the overall impression is that of a label or marking.

BIOPLANT Implant Systems (Implants and Abutments Systems) (K041655), Branemark Systems (K925777, K925779, K961728, K971706), and Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutment Systems) are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with roughened surfaces. The subject and predicate devices are similar in size and materials. All three systems offer abutment systems for cement-retained, screw-retained and overdenture restorations as well as associated accessories and instruments. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the Implant system.

#### 10-13. Conclusion

The data submitted in this 510(K) notification is to legally sale the following devices in U.S. market:

- Atlas Internal Fixture (Regular), 4.0mm, 1.8mm and 2.4mm Collar Height .
- Atlas Internal Fixture (Wide), 5.0mm, 1.8mm and 2.4mm Collar Height .
- Atias Internal Abutments Regular .

### - Wide

- Atlas External Fixture (Narrow), 3.3mm, 1.6mm Collar Height ●
- Atlas External Fixture (Regular), 4.0mm, 1.6mm Collar Height .
- Atlas External Fixture (Wide), 5.0mm, 1.6mm Collar Height .
- Atlas External Abutments Narrow ●

- Regular (Regular Neck, Wide Neck)

- Wide

- Atlas Submerged Fixture (Regular), 4.0mm ●
- Atlas Submerged Fixture (Wide), 5.0mm ●
- Atlas Submerged Abutments -- Regular ●

– Wide

The Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutment Systems) are substantially equivalent to the legally marked products such as BIOPLANT Implant Systems (Implants and Abutment Systems) (K041655) and Branemark Systems (K925777, K925779, K961728, K971706).

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Image /page/3/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around the perimeter of the circle. Inside the circle is an abstract image of an eagle. The eagle is facing to the right and has three lines representing its body and wings. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2005

Cowell Medi Company Limited C/O Ms. Dae Kyu Chang 13340 E. Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K050635

Trade/Device Name: Allfim Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 28, 2005 Received: June 30, 2005

Dear Ms. 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 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. 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 (see 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 - Ms. 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,

Sophie y. Michie Ows

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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## Indications for Use

510(k) Number (if known): k050635

Device Name : AllFIM IMPLANTN SYSTEM

#### (Atlas Fixtures and Atlas Shoulder Abutment Systems)

Indications for Use:

Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients.

Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options.

The devices covered by this submission are Atlas Fixtures, and Atlas Shoulder Abutments which are placed into dental implant to provide support for prosthetic reconstruction.

The non-hexa-shoulder abutment is designed for single crown use only. The hexa-shoulder abutment is designed for bridge use only

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Susan Runne

ision of Anesthesiology, General Hospital, Infection Control Clestnessology, Gene

510(k) Number: K050635