WN SYNOCTA GOLD ABUTMENT

K063789 · Straumann USA · NHA · May 10, 2007 · Dental

Device Facts

• Record ID: K063789
• Device Name: WN SYNOCTA GOLD ABUTMENT
• Applicant: Straumann USA
• Product Code: NHA · Dental
• Decision Date: May 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

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

Device Story

WN synOcta Gold Abutment is a dental component for endosseous implant systems. Device features an inset octagonal basal design; seated into dental implants via a mounting screw. Used by dental professionals in clinical settings to support cemented or screw-retained prosthetic restorations (crowns/bridges). Provides structural interface between implant and prosthesis; facilitates functional restoration for edentulous patients.

Clinical Evidence

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

Technological Characteristics

Gold abutment with inset octagonal basal design; includes mounting screw. Designed for integration with Straumann endosseous dental implant system. Mechanical fixation; non-software device.

Indications for Use

Indicated for use in partially or fully edentulous patients requiring prosthetic reconstructions, such as crowns or bridges, supported by endosseous dental implants.

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

• synOcta® Gold Abutment (K041295)

Submission Summary (Full Text)

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K063789

# 510(k) Summary

MAY 1 0 2007

- 1. Applicant's Name and Address Straumann USA (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 978-747-0023 Fax Number: Contact Person: Elaine Alan Regulatory Affairs Specialist
#### 2. Name of the Device

| Trade Name: | WN synOcta® Gold Abutment |
|----------------------|---------------------------------------|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| | 21 CFR 872.3640 |

- 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
synOcta® Gold Abutment, K041295

## 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. The device covered in this submission is an abutment.

The basal portion of the abutment has an inset octagonal design. The abutment is seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screwretained 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 or bridges.

# 6. Basis for Substantial Equivalence

The modified abutment is substantially equivalent to the currently marketed synOcta® Gold Abutment. 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 marketed device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized symbol of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

MAY 1 0 2007

Re: K063789

Trade/Device Name: WN SynOcta® Gold Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 13, 2007 Received: April 16, 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 (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,

Susa Rumpe
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

Device Name: WN synOcta® Gold Abutment

Indications for Use:

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

× 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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*Signature*

*Name and Title*

| of Anesthesiology, General Hospital, | |
|--------------------------------------|---------|
| Infection Control, Dental Devices | |
| 510(k) Number: | K063780 |

WN synOcta Gold Abutment December 20, 2006

Proprietary and Confidential

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