IMPLANTIUM PROSTHETICS

K052957 · Dentium Co., Ltd. · NHA · Jul 27, 2006 · Dental

Device Facts

• Record ID: K052957
• Device Name: IMPLANTIUM PROSTHETICS
• Applicant: Dentium Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Jul 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Implantium Prosthetics consists of various dental abutments (Healing, Combi, Screw, Dual, Angled, Ball, Temporary) and cover screws; used as an aid in prosthetic rehabilitation. Device components interface with dental implants to support prosthetic restorations. Operated by dental professionals in a clinical setting. Titanium alloy construction provides structural support for dental prostheses. No automated processing or software involved.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Pure Titanium Grade 4 (ASTM F 67-00) or Titanium alloy 6Al-4V (ASTM F 136-98). Surface: Partially TiN coated. Form factor: Various abutment types (Healing, Combi, Screw, Dual, Angled, Ball, Temporary) and cover screws. Non-sterile supply.

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, Dentium Co., Ltd. (K041368)
• Astra Tech Implants, Astra Tech Inc. (K931767)

Submission Summary (Full Text)

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052957

27-5 Leui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea 442-270 | Dentitum
Tel [phone] Fax [phone]

# 510(k) Summary

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

Date: ________________________________________________________________________________________________________________________________________________________________________

1. Company and Correspondent making the submission:

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

#### 2. Device:

Proprietary Name - Implantium Prosthetics Common Name - Abutment Classification Name - Endosseous dental implant abutment

#### 3. Predicate Device:

Implantium, Dentium Co., Ltd. K041368 Astra Tech Implants, Astra Tech Inc., K931767

# 4. Classifications Names & Citations:

21CFR 872.3630, NHA, Endosseous dental implant abutment, Class II

- 5. Description:
Implantium Prosthetics is a device made of titanium alloy intended for use as an aid in prosthetic rehabilitation. It consists of Healing Abutment, Combi Abutment, Screw Abutment, Dual Abutment, Angled Abutment, Ball Abutment, Temporary Abutment and Cover screw. Material is of Pure Titanium Grade 4 of ASTM F 67-00 or of Titanium alloy 6A1-4V of ASTM F 136-98. Its surface is partially TiN coated. It is supplied non-sterile.

## 6. Indication for use:

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

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27-5 Leui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea 442-270 | Demtiium
Tel [phone] Fax [phone]

Image /page/1/Picture/1 description: The image contains the word "Dentium" in a bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and the word is horizontally oriented.

### 7. Review:

Implantium Prosthetics has the same device characteristics as the predicate device. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Implantium Prosthetics has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations.

#### 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 Prosthetics is safe and effective and substantially equivalent to predicate devices as described herein.

END

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Image /page/2/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 a symbol that resembles a stylized eagle or bird with three wing-like shapes. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 2006

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

Re: K052957

.

Trade/Device Name: Implantium Prosthetics Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 12, 2006 Received: July 14, 2006

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 usc 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 mcan 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 fimited 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,

Chris Liu, 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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# Indications for Use

510(k) Number (if known): KoSZ957

Device Name: Implantium Prosthetics

Indications for Use: I Implantium Prosthetics is intended for use as an aid in prosthetic rehabilitation.

Prescription Use X (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Knut S. Betz DDS for Dr. Susan Renner
Page 1 of 1

cian of Anesthesiology, General Hospital,
cuon Control, Dental Devices
Number: K052957

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