TDS ABUTMENT FOR NOBEL BIOCARE REPLACE

K091026 · Pou YU Biotechnology Co., Ltd. · NHA · Jun 24, 2009 · Dental

Device Facts

• Record ID: K091026
• Device Name: TDS ABUTMENT FOR NOBEL BIOCARE REPLACE
• Applicant: Pou YU Biotechnology Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Jun 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TDS Abutment for Nobel Biocare Replace 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 Abutment for Nobel Biocare Replace consists of titanium and ceramic-titanium abutments used to support single or multi-unit cement-retained dental restorations. The device is secured to compatible Nobel Biocare dental implants using a Ti-6Al-4V ELI titanium abutment screw. It is intended for use by dental professionals in a clinical setting. The abutment acts as an interface between the endosseous implant and the prosthetic restoration, facilitating tooth replacement in the maxilla or mandible. Clinical benefit is derived from restoring masticatory function and aesthetics for edentulous patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium and ceramic-titanium; Abutment screw: Ti-6Al-4V ELI titanium. Form factor: Abutment components compatible with Nobel Replace implant systems (3.5mm, 4.3mm, 5.0mm, 6.0mm diameters). Mechanical connection to endosseous dental implants.

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. Contraindicated: highly angled abutments (30°) on implants <4 mm diameter in the posterior region due to limited implant strength.

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.)

Submission Summary (Full Text)

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501(k) Premarket Notification

TDS Abutment for Nobel Biocare Replace

K091026

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

### ADMINISTRATIVE INFORMATION

JUN 2 4 2009

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

#### Confidential

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#### INTENDED USE

TDS Abutment for Nobel Biocare Replace 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 Abutment for Nobel Biocare Replace are titanium and ceramic-titanium abutments designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutment for Nobel Biocare Replace are compatible with Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants.

#### EQUIVALENCE TO MARKETED DEVICE

Pou Yu Biotechnology Co. Ltd demonstrated that, for the purposes of FDA's regulation of medical devices, TDS Abutment 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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings and tail. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2009

Mr. Daniel Tsao Manager Pou Yu Biotechnology Company, Limited No. 6, Fugong RD Fusing Township Changhua City China, Taiwan 506

Re: K091026

Trade/Device Name: TDS Abutment for Nobel Biocare Replace Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 7, 2009 Received: April 13, 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- Ms. 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 electronic 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/CDRHOffices/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/cdrb/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 yours,

Susan Russe

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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## Indications for Use

510(k) Number (if known):

Device Name: TDS Abutment for Nobel Biocare Replace

Indications for Use:

TDS Abutment for Nobel Biocare Replace 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.

TDS Abutment for Nobel Biocare Replace is compatible with the following implant systems: Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants.

Note: Highly angled abutments (i.e. 30°) on implants with diameters less than 4 mm are not intended for the posterior region of the mouth due to limited strength of the implant.

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) |
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Yabut Sbetz DOS for Dr. Kevin Mulvey
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devic

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Confidential

510(k) Number: K091026