STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES

K071888 · Straumann USA · NHA · Oct 15, 2007 · Dental

Device Facts

• Record ID: K071888
• Device Name: STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
• Applicant: Straumann USA
• Product Code: NHA · Dental
• Decision Date: Oct 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures.

Device Story

P.004 RC Gold Abutment is a dental implant component; supports prosthetic reconstructions (crowns, bridges, overdentures). Device features engaging or non-engaging connections; engaging version uses 4 protrusions to lock into P.004 implant grooves; non-engaging version lacks this lock. Both types seat into implants via a mounting screw. Used by dental professionals in clinical settings to restore patient dentition; provides stable foundation for prosthetic teeth; improves oral function and aesthetics for edentulous patients.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Endosseous dental implant abutment; gold-based material; engaging (4-protrusion) or non-engaging connection types; screw-retained; mechanical interface with dental implants; class II device per 21 CFR 872.3630.

Indications for Use

Indicated for partially or fully edentulous patients requiring prosthetic reconstruction support via dental implants. Used for cemented and screw-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

• Straumann P.004 Dental Implants (K062129)
• synOcta® Gold Abutment (K041295)

Submission Summary (Full Text)

{0}------------------------------------------------

## K071888

1082

## Section I 510(k) SUMMARY

0CT 1 5 2007

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

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: July 6, 2007

#### 2. Name of the Device

| Trade Name: | P.004 RC Gold Abutment for Bridge |
|----------------------|---------------------------------------|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| | 21 CFR 872.3630 |

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

Straumann P.004 Dental Implants, K062129 synOcta® Gold Abutment, K041295

#### 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 abutments.

Abutments can have an engaging or non-engaging connection to the implant. The basal portion of the engaging abutment has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. Non-engaging abutments do not lock into the implant via the protrusion/groove connection. Both abutments are seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations.

#### 5. Intended Use of the Device

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures.

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#### 6. Technological Characteristics

The proposed abutment is substantially equivalent to the currently marketed devices. The intended use is substantially equivalent to the predicate devices. The proposed abutment has 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 consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

OCT 1 5 2007

Re: K071888 Trade/Device Name: P.004 Abutment

Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 3, 2007 Received: October 4, 2007

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 (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,

Sunile y. Mchais Ous.

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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K071888

# INDICATIONS FOR USE STATEMENT

Device Name: P.004 Abutment

Indications for Use:

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

× Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of GDRH, Office of Device Evaluation (ODE)

*Sun Prime*

(Division Sign-Off)

Page 1 of 1

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K071888 |
|----------------|---------|
|----------------|---------|

510(k) Submission: P.004 Gold Abutments July 6, 2007

Proprietary and Confidential

Straumann US Page 5