P.004 NC ANATOMIC ABUTMENTS

K071357 · Institut Straumann AG · NHA · Sep 26, 2007 · Dental

Device Facts

• Record ID: K071357
• Device Name: P.004 NC ANATOMIC ABUTMENTS
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Sep 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

P.004 NC Anatomic Abutments are components of the Straumann Dental Implant System; placed into endosseous dental implants to provide support for prosthetic restorations (crowns, bridges, overdentures). Used by dental professionals in clinical settings for partially or fully edentulous patients. Device serves as an interface between the implant and the final prosthesis. Benefits include restoration of dental function and aesthetics.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Endosseous dental implant abutment; material composition and design identical to predicate devices; intended for use with Straumann dental implant systems.

Indications for Use

Indicated for partially or fully edentulous patients requiring support for prosthetic reconstructions including crowns, bridges, and overdentures in 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

• P.004 RC Anatomic Abutments (K062129)

Submission Summary (Full Text)

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SEP 2 6 2007

## Section J 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: 978-747-2507 Fax Number: 978-747-0023 Paige Sweeney Contact Person: Manager, Requlatory Affairs Date of Submission: May 11, 2007

#### 2. Name of the Device

| Trade Name: | P.004 NC Anatomic Abutments |
|----------------------|---------------------------------------|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| Regulation Number: | 21 CFR 872.3630 |

- e Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
P.004 RC Anatomic Abutments, K062129

#### 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. The devices covered in this submission are anatomic abutments.

Abutments are placed into dental implants to provide support for prosthetic restorations.

#### 5. Intended Use of the Device

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

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#### 6. Technological Characteristics

The modified Anatomic Abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed closure screws have the same material composition, basic design and fundamental operating principles to the currently marketed devices.

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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 caduceus, which is a symbol of medicine, with three figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Institut Straumann AG C/O Ms. Paige Sweeney Manager, Regulatory Affairs Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

Re: K071357

Trade/Device Name: P.004 NC Anatomic Abutments Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 2, 2007 Received: August 3, 2007

Dear Ms. Sweeney:

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.

SEP 2 6 2007

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. Sweeney

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 (OS) 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.

Syndite y. Richards

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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# k071357

### INDICATIONS FOR USE STATEMENT

Device Name: P.004 NC Anatomic Abutments

Indications for Use:

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

| Prescription Use | X |
|-----------------------------|------------------------|
| (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

| (Division Sign-Off) | |
|---------------------------------------------------------------------------------|---------|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K071357 |

510(k) Submission: P.004 NC Anatomic Abutments May 11, 2007 Proprietary and Confidential .

Straumann US Page 5