STRAUMANN WN CARES TITANIUM ABUTMENT

K082764 · Institut Straumann AG · NHA · Oct 1, 2008 · Dental

Device Facts

• Record ID: K082764
• Device Name: STRAUMANN WN CARES TITANIUM ABUTMENT
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Oct 1, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures. The Straumann WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.

Device Story

Straumann WN CARES Titanium Abutment is a dental component designed for integration with endosseous dental implants. It serves as an interface between the implant and a prosthetic restoration (crowns, bridges, or overdentures). The device is placed into the dental implant by a dental professional in a clinical setting. It provides structural support for cement-retained restorations, facilitating the replacement of missing teeth in partially or fully edentulous patients. The abutment functions as a mechanical connector, ensuring stability for the final prosthetic.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarity to the predicate device.

Technological Characteristics

Titanium abutment for endosseous dental implants. Mechanical design for cement-retained prosthetic support. Class II device (21 CFR 872.3630).

Indications for Use

Indicated for single tooth replacements and multiple tooth restorations in patients requiring prosthetic support via dental implants. For use with cement-retained 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

• RN CARES Titanium Abutment (K052272)

Submission Summary (Full Text)

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Kosa764

## Section I 510(k) Summary

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

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: September 19, 2008

#### 2. Name of the Device

| Trade Name: | Straumann WN CARES Titanium Abutment |
|----------------------|---------------------------------------|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| Regulation Number: | $§872.3630$ |

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

RN CARES Titanium Abutment, K052272

#### 4. Description of the Device

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.

#### 5. Intended Use of the Device

Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The Straumann WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cementretained.

#### 6. Technological Characteristics

The proposed abutment is substantially equivalent to the currently cleared device. The intended use is identical to the predicate device. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently cleared device.

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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 with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 01 2008

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

Re: K082764

Trade/Device Name: Straumann WN CARES Titanium Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 19, 2008 Received: September 22, 2008

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 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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Pagc 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); 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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

JHKmuele-Lindmy forell

Chiu S. Lin. Ph. D Division 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: Straumann WN CARES Titanium Abutment

Indications for Use:

Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures.

The Straumann WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.

× Prescription Use (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susa Russo

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

510(k) Number: KD82764

510(k) Submission: WN CARES Titanium September 19, 2008

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