P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS

K081005 · Institut Straumann AG · NHA · May 2, 2008 · Dental

Device Facts

• Record ID: K081005
• Device Name: P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: May 2, 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 and overdentures. The P.004 NC CARES Titanium Abutment is indicated for cement-retained restorations. The abutment can be used in single tooth replacements and multiple tooth restorations. The P.004 NC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The abutment is indicated for cemented or screw-retained (directly veneered) restorations.

Device Story

P.004 NC CARES Titanium and Ceramic Abutments are components of the Straumann Dental Implant System. Abutments connect to endosseous dental implants to support prosthetic restorations including crowns, bridges, and overdentures. Used by dental professionals in clinical settings for patients requiring tooth replacement. Titanium version supports cement-retained restorations; ceramic version supports cemented or screw-retained (directly veneered) restorations. Device facilitates functional and aesthetic restoration of dentition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant abutments. Materials: Titanium and Ceramic. Design and operating principles consistent with predicate devices. No software or electronic components.

Indications for Use

Indicated for partially or fully edentulous patients requiring support for prosthetic restorations (crowns, bridges, overdentures). Titanium abutment indicated for cement-retained restorations; Ceramic abutment indicated for cemented or screw-retained (directly veneered) restorations. Applicable for single or multiple tooth replacements.

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

• RC CARES Titanium Abutment (K072151)
• RC CARES Ceramic Abutment (K072151)

Submission Summary (Full Text)

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K081005

Section I 510(k) Summary

MAY - 2 2008

### 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: April 4, 2008

#### 2. Name of the Device

| Trade Name: | P.004 NC CARES Titanium Abutment<br>P.004 NC CARES Ceramic 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)

RC CARES Titanium Abutment, K072151 RC CARES Ceramic Abutment, K072151

#### 4. Description of the Device

The Straumann P.004 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, bridges and overdentures. The P.004 NC CARES Titanium Abutment is indicated for cement-retained restorations. The abutment can be used in single tooth replacements and multiple tooth restorations. The P.004 NC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The abutment is indicated for cemented or screw-retained (directly veneered) restorations.

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#### 6. Technological Characteristics

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

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY - 2 2008

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

Re: K081005

Trade/Device Name: P.004 NC Cares Titanium and Ceramic Abutments Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 7, 2008 Received: April 8, 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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## 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); 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.

Clare

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 Statement

P.004 NC CARES Titanium and NC CARES Ceramic Device Name: Abutments

Indications for Use:

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

The P.004 NC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations.

The P.004 NC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained.

Susa Prosser

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

510(k) Number: K081005

× 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)

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510(k) Submission: P.004 NC CARES Titanium and NC Ceramic Abutments April 7, 2008

Straumann US Page 5