STRAUMANN MODIFIED DENTAL ABUTMENT

K091701 · Institut Straumann AG · NHA · Dec 22, 2009 · Dental

Device Facts

• Record ID: K091701
• Device Name: STRAUMANN MODIFIED DENTAL ABUTMENT
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Dec 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Modified Dental Implant Abutments are indicated for screw-retained singletooth restorations and cement-retained single tooth and bridge restorations (via meso structures.)

Device Story

Device consists of endosseous dental implant abutments; part of Straumann Dental Implant System. Abutments placed into dental implants by dental professionals; provide support for prosthetic restorations including crowns and bridges. Used for single-tooth or multiple-tooth restorations. Mechanical interface between implant and prosthesis. No software or electronic components.

Clinical Evidence

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

Technological Characteristics

Endosseous dental implant abutment; metallic construction; mechanical interface for prosthetic support. No software, electronics, or energy sources.

Indications for Use

Indicated for patients requiring prosthetic restoration of Straumann dental implants, specifically for screw-retained single-tooth restorations and cement-retained single-tooth and bridge restorations.

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

• Straumann Dental Implant Abutment (K062129)

Submission Summary (Full Text)

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# Section I 510(k) SUMMARY

#### 1. Applicant's Name and Address

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 978-747-2513 978-747-0023 Fax Number: Elaine Alan Contact Person: Requlatory Affairs Specialist June 8, 2009

Date of Submission:

#### 2. Name of the Device

Modified Dental Implant Abutment Trade Name: Common Name: Dental Abutment Endosseous Dental Implant Abutment Classification Name: 21 CFR §872.3630 Regulation Number:

### Legally Marketed Device to which Equivalence is Claimed 3. (Predicate Device)

Straumann Dental Implant Abutment, K062129

#### Description of the Device 4.

The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are abutments.

#### 5. Intended Use of the Device

Abutments are placed into dental implants to provide support for prosthetic restorations such as crowns and bridges. Abutments can be used in single tooth replacements and multiple tooth restorations.

#### Technological Characteristics 6.

The modified abutments are substantially equivalent to the currently cleared devices. The intended use is identical to the predicate devices. The proposed abutments have the same basic design and fundamental operating principles to the currently cleared devices.

DEC 22 2009

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird with its wings spread.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Institut Straumann AG C/O Ms. Elaine Alan Regulatory Affairs, Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

# DEC 22 2009

Re: K091701

Trade/Device Name: Modified Dental Implant Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 15, 2009 Received: December 16, 2009

Dear Ms. Alan:

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. Alan

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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 STATEMENT

Device Name: Modified Dental Implant Abutment

Indications for Use:

Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.

Modified Dental Implant Abutments are indicated for screw-retained singletooth restorations and cement-retained single tooth and bridge restorations (via meso structures.)

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

RSbert DNS for Brk. P. Muly (Acting)
(Division Sign Off)

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

510(k) Number: K091701