IMPLANTIUM PROSTHETICS

K070228 · Dentium Co., Ltd. · NHA · Nov 20, 2007 · Dental

Device Facts

• Record ID: K070228
• Device Name: IMPLANTIUM PROSTHETICS
• Applicant: Dentium Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Nov 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Implantium Prosthetic is intended for use as an aid in prosthetic rehabilitation.

Device Story

Implantium Prosthetics are dental implant abutments used for prosthetic rehabilitation. Components include healing abutments, dual milling abutments, dual abutments, multipurpose abutments, solid abutments, direct casting abutments, cover screws, and screws. Device is fabricated from pure titanium or titanium alloy; surfaces may be partially TiN coated or uncoated. Supplied non-sterile; requires sterilization by user. Used by dental professionals in clinical settings to support prosthetic restorations.

Clinical Evidence

No clinical data; substantial equivalence based on design and material characteristics.

Technological Characteristics

Materials: Pure titanium or titanium alloy. Surface: Partially TiN coated or uncoated. Components: Healing abutment, dual milling abutment, dual abutment, multipurpose abutment, solid abutment, direct casting abutment, cover screw, and screw. Sterilization: Non-sterile, user-sterilized.

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implant abutments.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• Implantium Prosthetic, Dentium Co., Ltd. (K052957)

Submission Summary (Full Text)

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## 510(k) Summary

## KO70228

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: January 19, 2007

- Company and Correspondent making the submission: 】.

| | Company |
|-------------------------|-----------------------------------------------------------------------|
| Name | Dentium Co., Ltd. |
| Address | 27-5 Leui-Dong, Yeongtong-Gu,<br>Suwon-Si, Gyeonggi-Do, Korea 442-270 |
| Phone<br>Fax<br>Contact | [phone]<br>[phone]<br>K. Y. Yoon |

NOV 2 0 2007

- 2. Device:
Proprietary Name - Implantium Prosthetic Common Name - Dental Implant Classification Name - Endosseous dental implant abutment

- 3. Predicate Device: Implantium Prosthetic, Dentium Co., Ltd., K052957
- 4. Classifications Names & Citations: 21CFR 872.3630, NHA, Endosseous dental implant abutment, Class II
- ડા Description:

Implantium Prosthetics is a device made of pure titanium or titanium alloy intended for use as an aid in prosthetic rehabilitation. It consists of Healing Abutment, Dual Milling Abutment, Dual Abutment, Multipurpose Abutment, Solid Abutment, Direct Casting Abutment, Cover Screw and screw. Its surfaces are partially TiN coated or uncoated. It is supplied non-sterile and sterilized by the recommended sterilization method in the instructions for use.

The Implantium Prosthetic is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The Implantium Prosthetic is substantially equivalent in design, function and intended use to the predicate.

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- 6. Indication for use: Implantium Prosthetic is intended for use as an aid in prosthetic rehabilitation.
- 7. Review:

Implantium Prosthetic has the same material, design, use and device characteristics as the predicate device.

- 8. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentium Co., Ltd. concludes that Implantium Prosthetic is safe and effective and substantially equivalent to the predicate device as described herein.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2007

Dentium Company, Limited C/O Ms. Cathryn N. Cambria Consultant Arkin Consulting Group 5536 Trowbridge Drive Atlanta, Georgia 30338

Re: K070228

Trade/Device Name: Implantium Prosthtics Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 11, 2007 Received: October 23, 2007

Dear Ms. Cambria:

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. Cambria

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.

Susan Kunoe
Chi-Lien, Ph.D.

7 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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510(k) Number K_010228

Implantium Prosthetics Device Name:

Indication for use: Implantium Prosthetics is intended for use as an aid in prosthetic rehabilitation.

OR Prescription Use_________X (Per 21CFR801 Subpart D)

Over-The-Counter Use (Per 21CFR807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| K # Number: | K070228 |
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