STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING

K061277 · Straumann USA · NHA · Apr 12, 2007 · Dental

Device Facts

• Record ID: K061277
• Device Name: STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING
• Applicant: Straumann USA
• Product Code: NHA · Dental
• Decision Date: Apr 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Straumann C.A.R.E.S. Ceramic Coping is a device that provides support for cement-retained prosthetic reconstructions, such as crowns an bridges. The Straumann C.A.R.E.S. Ceramic Coping is of particular interest in the anterior, canine, and premolar regions where there are high esthetic demands. The coping will be uniquely customized for an individual then placed on the dental implant.

Device Story

Custom ceramic coping for endosseous dental implants; provides support for cement-retained crowns and bridges. Device customized for individual patient anatomy to meet esthetic demands. Fixed to synOcta 1.5 abutment, which attaches to dental implant. Used in dental clinic setting by clinicians. Utilizes CAD/CAM milling process to create patient-specific geometry. Benefits include natural soft tissue margin appearance and high-quality crown restoration.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and process similarity to legally marketed predicate devices.

Technological Characteristics

Ceramic coping for endosseous dental implants. Designed for cement-retained restorations. Utilizes CAD/CAM milling process. Material composition and design identical to predicate Vident Ceramic Hextop Abutment (K012473).

Indications for Use

Indicated for patients requiring cemented prosthetic restorations, including single tooth replacements and multiple tooth restorations (crowns or bridges), particularly in anterior, canine, and premolar regions with high esthetic demands.

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 C.A.R.E.S. Titanium Abutment (K052272)
• Straumann's synOcta® Meso Abutment (K033243)
• Vident Ceramic Hextop Abutment and synOcta® In-Ceram Coping (K012473)
• ITI 1.5 mm synOcta Abutment (K022859)
• synOcta Abutments and Prosthetic Accessories (K990342)

Submission Summary (Full Text)

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

K061277

APR 1 2 2007

# 510 (k) Summary

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

Straumann Manufacturing (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, Massachusetts 01810 Telephone Number: 800-448-8168 978-747-0031 Fax Number: Contact Person: Elaine Alan, Regulatory Affairs Specialist Regulatory and Clinical Affairs

#### 2. Name of the Device

| Trade Name: | Straumann Computer Aided Restoration Service<br>(C.A.R.E.S.) Ceramic Coping |
|----------------------|-----------------------------------------------------------------------------|
| Common Name: | Abutment for endosseous implant |
| Classification Name: | Accessory to dental implant<br>21 CFR 872.3630 |

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

Straumann C.A.R.E.S. Titanium Abutment, K052272
Straumann's synOcta® Meso Abutment, K033243 Vident Ceramic Hextop Abutment and synOcta® In-Ceram Coping, K012473 ITI 1.5 mm synOcta Abutment, K022859 and synOcta Abutments and Prosthetic Accessories, K990342

### 4. Description of the Device

The Straumann Dental Implant System is an integrated system of endosseous dental implants designed to support prosthetic restorations (crowns, bridges, overdentures). The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The subject device, the Straumann C.A.R.E.S. Ceramic Coping, is designed to be custom modified for a particular patient, the coping is fixed to a synOcta® 1.5 abutment which is then fixed to the implant. The ceramic coping provides support for prosthetic reconstructions, such as crowns or bridges.

The Straumann C.A.R.E.S. Ceramic Coping is intended for cemented restorations and can be customized to meet high anatomical and esthetic demands. The esthetic properties of the Straumann C.A.R.E.S. Ceramic Coping are designed to create a

{1}------------------------------------------------

natural appearance of the soft tissue margin as well as excellent results for crown restoration.

### 5. Intended Use of the Device

The Straumann C.A.R.E.S. Ceramic Coping is a device that provides support for cement-retained prosthetic reconstructions, such as crowns an bridges. The Straumann C.A.R.E.S. Ceramic Coping is of particular interest in the anterior, canine, and premolar regions where there are high esthetic demands. The coping will be uniquely customized for an individual then placed on the dental implant.

### 6. Basis for Substantial Equivalence

The Straumann C.A.R.E.S. Ceramic Coping is substantially equivalent to the previously cleared predicate devices intended to be used with endosseous dental implants. The design of the subject coping is very similar and the indications for use are identical to the previously cleared copings in the ITI 1.5 mm synOcta Abutment, K022859 and synOcta Abutments and Prosthetic Accessories, K990342. Straumann C.A.R.E.S. Titanium Abutment K052272 and Straumann synOcta® Meso Abutment K033243. Technological characteristics of the device, including material composition, principles of operation, and basic design are identical to the predicate device Vident Ceramic Hextop Abutment and synOcta® In-Ceram Coping, K012473. The C.A.R.E.S. Ceramic Coping uses the same software and milling process as the predicate Straumann C.A.R.E.S. Titanium Abutment, K052272.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2007

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

Re: K061277

Trade/Device Name: Straumann C.A.R.E.S. Ceramic Coping Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 19, 2007 Received: March 20, 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.

{3}------------------------------------------------

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,

Snytte y. Michael Dmd

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

{4}------------------------------------------------

# Indications for Use

#### K061277 510(k) Number (if known):

Straumann C.A.R.E.S. Ceramic Coping Device Name:

#### Indications for Use:

Copings are intended to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Ceramic Coping is indicated for cemented restorations. The coping can be used in single tooth replacements and multiple tooth restorations.

1 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)

Suanbunpo

of Anectinesiology, Coneral Hospital,
won Control, Demal Devices

(k) Number 16661277