STRAUMANN TEMPORARY COPING

K041070 · The Straumann Co. · NHA · Jul 23, 2004 · Dental

Device Facts

• Record ID: K041070
• Device Name: STRAUMANN TEMPORARY COPING
• Applicant: The Straumann Co.
• Product Code: NHA · Dental
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration.

Device Story

Straumann Temporary Coping serves as a base for temporary dental restorations. Device fits over Straumann solid abutments; features radial projections to facilitate retention of added acrylic or composite materials. Used in dental clinic settings by dental professionals. Output is a structural foundation for temporary restoration, enabling patient to maintain function and aesthetics during interim period before final prosthetic placement.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Temporary coping designed to fit over Straumann solid abutments. Features radial projections for material retention. Mechanical device; no energy source, software, or electronic components.

Indications for Use

Indicated for use as a base for temporary dental restorations in patients requiring temporary prosthetic support over Straumann solid abutments.

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

• Universal Dental Coping (K010467)
• Hex-Lock Temporary Abutment (K014050)
• ProTect Abutment (Unknown)
• COC Abutment Temporary Cap (Unknown)

Submission Summary (Full Text)

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KC41070

## ATTACHMENT 1 - 510(k) Summary

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.

### Applicant's Name and Address .
→ :

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 781-890-0001 Telephone Number: 781-890-6464 Fax Number: Linda Jalbert Contact Person: Director, Requiatory Affairs

### 2. Name of the Device

| Proposed Trade Name: | Straumann Temporary Coping |
|----------------------|-------------------------------------------|
| Common Name: | Temporary coping |
| Classification Name: | Accessory to Dental Implant Abutment, NHA |

## Legally Marketed Devices to which Equivalence is Claimed (Predicate ന് Devices)

| Manufacturer | Device | 510(k) |
|-------------------------------|-----------------------------|---------|
| Simplified<br>Implant Systems | Universal Dental Coping | K010467 |
| Centerpulse<br>Dental | Hex-Lock Temporary Abutment | K014050 |
| Friadent | ProTect Abutment | Unknown |
| Lifecore | COC Abutment Temporary Cap | Unknown |

### Description of the Device and Intended Use ব :

The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration. The temporary coping fits over the Straumann solid abulments and has radial projections that facilitate the retention of added acrylic or composite materials to form a temporary restoration.

### 5. Basis for Substantial Equivalence

The Straumann Temporary Coping is substantially equivalent to the predicate devices since it has a similar design and the same intended use. Like all of the predicate devices, the subject device functions as a base for a temporary restoration. Acrylic or composite material is added over the coping to form the temporary restoration.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Ms. Linda Jalbert Vice President, Regulatory & Clinical Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451

Re: K041070

Trade/Device Name: Straumann Temporary Coping Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: April 23, 2004 Received: April 26, 2004

Dear Ms. Jalbert:

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. Jalbert

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/dsma/dsmamain.html

Sincerely yours,

Susa Lumer

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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K041070

# Indications for Use

510(k) Number (if known):

Device Name: Temporary Coping

Indications For Use:

The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration.

× 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)

Susan Runne

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

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510(k) Number: K041070