NARROW NECK TEMPORARY COPING

K070744 · Institut Straumann AG · NHA · Jun 29, 2007 · Dental

Device Facts

• Record ID: K070744
• Device Name: NARROW NECK TEMPORARY COPING
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants Ø3.3mm Narrow Neck for use up to six months.

Device Story

The Narrow Neck Temporary Coping is a prosthetic component of the Straumann Implant System. It serves as a base for the fabrication of individual temporary restorations and small cemented temporary bridges. The device is intended for use on Straumann Standard Plus Ø3.3mm Narrow Neck implants. It is utilized in a clinical setting by dental professionals to support temporary prosthetic solutions for partially or fully edentulous patients for a period not exceeding six months.

Technological Characteristics

The device is a temporary coping component for endosseous dental implants. It is constructed from the same materials as the predicate devices. It is a mechanical prosthetic accessory designed for use with the Straumann Standard Plus Ø3.3mm Narrow Neck Implant system.

Indications for Use

Indicated for patients requiring temporary restorations or small cemented temporary bridges supported by Straumann Standard Plus Ø3.3mm Narrow Neck endosseous dental implants for a duration of up to six months.

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

• Titanium Coping for Anterior Implant (K032498)
• RN synOcta® Temporary Meso Abutment (K051717)

Submission Summary (Full Text)

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070744

# SECTION I 510(k) Summary

JUN 2 9 2007

## 1. Applicant's Name and Address

Straumann USA (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810

Telephone Number: Fax Number: Contact Person:

Date of Submission:

978-747-2513 978-747-0023 Elaine Alan Regulatory Affairs Specialist March 15, 2007

## 2. Name of the Device

Trade Name: Common Name: Classification Name: Narrow Neck Temporary Coping Accessory to Endosseous Dental Implant Accessory to Endosseous Dental Implant 21 CFR 872.3640

- 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) K032498, Titanium Coping for Anterior Implant RN synOcta® Temporary Meso Abutment. K051717
#### 4. Description of the Device

The Straumann 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 a temporary coping.

The Straumann Narrow Neck Temporary Coping intended to serve as a base for temporary restorations. The temporary coping is for use on the Straumann Standard Plus Ø3.3mm Narrow Neck Implant.

#### 5. Intended Use of the Device

The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants Ø3.3mm Narrow Neck for use up to six months.

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#### റ. Basis for Substantial Equivalence

The proposed coping is substantially equivalent to the previously cleared Titanium Coping for Anterior Implant, K032498, and the RN SynOcta® Temporary Meso Abutment, K051717. The proposed device is substantially equivalent in intended use, operating principle and basic design and is made of the same materials as 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with its wings forming a flowing, abstract design.

JUN 2 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K070744

Trade/Device Name: Narrow Neck Temporary Coping Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 7, 2007 Received: June 8, 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 vour 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.

Susan Runner

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

510(k) Number (if known): K ♡フロ フィイ

Narrow Neck Temporary Coping Device Name:

Indications for Use:

The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants Ø3.3mm Narrow Neck for use up to six months.

× 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)

Suser Ruape

ision Sign-Off) Civision of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number: K070744

Narrow Neck Temporary Coping March 15, 2007

Propriety and Confidential

Straumann USA Page 5 of 27