SPI ART ABUTMENTS

K061807 · Thommen Medical AG · NHA · Jul 31, 2006 · Dental

Device Facts

• Record ID: K061807
• Device Name: SPI ART ABUTMENTS
• Applicant: Thommen Medical AG
• Product Code: NHA · Dental
• Decision Date: Jul 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SPI® ART Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI ART Abutments are contraindicated for free-end bridges or bridges with more than one intermediate pontic element.

Device Story

SPI® ART Abutment is a zirconia (Y-TZP) dental implant component used with SPI System dental implants. Device provides structural support for crowns, bridges, or overdentures. Used in dental clinics by dentists. Design mirrors existing titanium SPIEASY and SPI RETAIN abutments. Zirconia material selected for compatibility with ceramic cemented restorations. Device facilitates prosthetic restoration of missing teeth, improving patient function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Zirconium oxide (Y-TZP). Form factor: Dental implant abutment, available in two sizes. Designed for ceramic cemented restorations. Mechanical design is identical to titanium SPIEASY and SPI RETAIN abutments.

Indications for Use

Indicated for patients requiring dental implant-supported crowns, bridges, or overdentures in the maxillary or mandibular arch. Contraindicated for free-end bridges or bridges with more than one intermediate pontic element.

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.)

Reference Devices

• SPIEASY abutments
• SPI RETAIN milling abutments

Submission Summary (Full Text)

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510(k) Summary

K061807

# SPI® ART Abutment

510(k) Summary

JUL 3 1 2006

# Thommen Medical AG SPI® ART Abutment

### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Thommen Medical AG<br>Hauptstrasse 26d<br>CH-4437 Waldenburg, Switzerland<br>Telephone [phone]<br>Fax [phone] |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Orlando Antunes |

Representative/Consultant: Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone [phone] Fax [phone]

### DEVICE NAME

| Classification Name: | Abutment, Implant, Dental, Endosseous |
|-------------------------|--------------------------------------------|
| Trade/Proprietary Name: | SPI® ART Abutment |
| Common Name: | Endosseous Dental Implant System Component |

## ESTABLISHMENT REGISTRATION NUMBER

The Establishment Registration number for Thommen Medical AG is 3003836985. The Owner/Operator number is 9051144.

### DEVICE CLASSIFICATION

Endosseous dental implant abutments are Class II devices (21 CFR 872.3630). The device classification is reviewed by the Dental Devices Branch. The product code for "Abutment, Implant, Dental, Endosseous" is NHA.

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SPI® ART Abutment

#### INDICATIONS FOR USE

SPI® ART Abutments are intended to be used in conjunction with SPI System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.

SPI ART Abutments are contraindicated for free-end bridges with more than one intermediate pontic element.

#### DEVICE DESCRIPTION

Thommen SPI ART Abutments are zirconia dental implant abutments for use with the SPI Dental Implant System.

#### Design

Both the SPI ART Abutment and SPI ART Grinding (Milling) Abutment have the same design as their titanium counterparts, SPIEASY abutments for cemented restoration and SPI RETAIN milling abutments. Each of the SPI ART abutment types comes in two sizes.

Material

SPI ART abutments are made from zirconium oxide (Y-TZP) and are designed specifically for use with ceramic cemented restorations.

EQUIVALANCE TO MARKETED DEVICE

Thommen Medical AG has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the SPI ART Abutment is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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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 with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2006

Thommen Medical AG C/O Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K061807

Trade/Device Name: SPI® Art Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 23, 2006 Received: June 27, 2006

Dear Mr. Larson:

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, iisting 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 - Mr. Larson

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 vours.

Signature

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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510(k) Premarket Notification

SPI® ART Abutment

# 06/807 INDICATIONS FOR USE

510(k) Number (if known):

SPI® ART Abutment Device Name:

Indications for Use:

SPI® ART Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.

SPI ART Abutments are contraindicated for free-end bridges or bridges with more than one intermediate pontic element.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muller Sir HSS

Sign-Ciff) .on Siyn-Cift)
An of Anesthesiology, General Hospitalian of Anesthesion of Anesther in of Anesthestors

Number Ko. 1801

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