TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK

K091392 · Pou YU Biotechnology Co., Ltd. · NHA · Jul 30, 2009 · Dental

Device Facts

• Record ID: K091392
• Device Name: TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK
• Applicant: Pou YU Biotechnology Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

TDS Titanium Abutment for Nobel Biocare Branemark is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Device Story

TDS Titanium Abutment is a dental implant component; fabricated from Ti-6Al-4V ELI titanium. Device functions as an interface between endosseous dental implants and dental prostheses; secured to implants via a titanium abutment screw. Used by dental professionals in clinical settings to support cement-retained single or multi-unit restorations. Provides structural support for prosthetic teeth in partially or fully edentulous patients; restores masticatory function and aesthetics.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Material: Ti-6Al-4V ELI titanium. Design: Preformed abutment for external hex dental implant connections (≥ 2.4mm flat-to-flat). Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple tooth prostheses supported by dental implants in the maxilla or mandible. Compatible with specific external hex implant systems (Nobel Biocare, 3i, BioHorizons, Lifecore) with flat-to-flat dimensions ≥ 2.4mm.

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.)

Reference Devices

• Nobel Biocare Branemark System Mk III Groovy
• Nobel Biocare Branemark System Mk III Shorty
• Nobel Biocare Branemark System Zygoma
• Nobel Biocare NobelSpeedy Groovy
• Nobel Biocare NobelSpeedy Shorty
• 3i Nano Tite External Hex Connection Implants
• 3i Full OSSEOTITE External Hex Connection Implants
• 3i OSSEOTITE External Hex Connection Implant
• BioHorizons Maestro External Hex Implants
• Lifecore Restore External Hex Implant Systems

Submission Summary (Full Text)

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TDS Titanium Abutment for Nobel Biocare Branemark

K091392

# 510(k) Summary Pou Yu Biotechnology Co., Ltd TDS Titanium Abutment for Nobel Biocare Branemark

JUL 30 2009

# ADMINISTRATIVE INFORMATION

Manufacturer Name:

Pou Yu Biotechnology Co., Ltd. No. 6 Fugong Rd. Fusing Township Changhua County 506, Taiwan Telephone: [phone] x5122 Fax: [phone]

Official Contact:

Daniel Tsao

# DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Product Code: Classification Panel: Reviewing Branch:

TDS Titanium Abutment for Nobel Biocare Branemark, Dental implant abutment Endosseous dental implant abutment Class II, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch

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#### INTENDED USE

TDS Titanium Abutment for Nobel Biocare Branemark is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

### DEVICE DESCRIPTION

TDS Titanium Abutment for Nobel Biocare Branemark are titanium abutments made of Ti-6A1-4V ELI titanium designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is also made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Titanium Abutment for Nobel Biocare Branemark is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

# EQUIVALENCE TO MARKETED DEVICE

Pou Yu Biotechnology Co. Ltd demonstrated that, for the purposes of FDA's regulation of medical devices, TDS Titanium Abutment for Nobel Biocare Branemark is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three distinct wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is present, indicating the organization associated with the logo. The logo is simple and uses a limited color palette, likely intended for official use.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel Tsao Manager Pou Yu Biotechnology Company, Limited No. 6 Fugong Road Fusing Township Changhua County 506 TAIWAN

JUL 3 0 2009

Re: K091392

Trade/Device Name: TDS Titanium Abutment for Nobel Biocare Branemark Regulation Number: 21 CFR 872.3630 Regulation Name: Preformed Cusp Regulatory Class: II Product Code: NHA Dated: May 8, 2009 Received :- May 21, 2009

Dear Mr. Tsao:

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 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. Tsao

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOtfices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 vours.

Susan Runner

Susan Runner, D.D.S., M.A. Acting 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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501(k) Premarket Notification

TDS Titanium Abutment for Nobel Biocare Branemark

#### Indications for Use

510(k) Number (if known): __K091392__

Device Name: TDS Titanium Abutment for Nobel Biocare Branemark

Indications for Use:

TDS Titanium Abutment for Nobel Biocare Branemark is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

This device is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare: Branemark System® Mk III Groovy, Branemark System® Mk III Shorty, Branemark System® Zygoma, NobelSpeedy Groovy, NobelSpeedy Shorty; 3i: Nano Tite External Hex Connection Implants, Full OSSEOTITE External Hex Connection Implants, OSSEOTITE External Hex Connection Implant; BioHorizons: Maestro - External Hex Implants; Lifecore: Restore External Hex Implant Systems.

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)

| | <i>Susanne</i> |
|----------------------------------------------|----------------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |

| 510(k) Number: | <i>KOP1392</i> |
|----------------|----------------|
|----------------|----------------|

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