SPI VARIOMULTI ANGLED ABUTMENT

K090153 · Thommen Medical AG · NHA · Mar 27, 2009 · Dental

Device Facts

• Record ID: K090153
• Device Name: SPI VARIOMULTI ANGLED ABUTMENT
• Applicant: Thommen Medical AG
• Product Code: NHA · Dental
• Decision Date: Mar 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.

Device Story

SPI® VARIOmulti Angled Abutments are prefabricated dental implant abutments designed for use with the SPI® Dental Implant System. The device features an internal connection to the implant and an external hex prosthetic attachment. It is used by dental professionals to support multi-unit, screw-retained restorations, including splinted crowns, bridges, and overdentures. The abutment facilitates the prosthetic connection between the endosseous implant and the final restoration, aiding in the rehabilitation of missing teeth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Prefabricated dental implant abutment; internal connection to implant; external hex prosthetic attachment; metallic construction; intended for multi-unit, screw-retained restorations.

Indications for Use

Indicated for patients requiring support for splinted crowns, bridges, or overdentures in the maxillary or mandibular arch using SPI® System 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.)

Submission Summary (Full Text)

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

510(k) Summary

MAR 2 7 2009

# 510(k) Summary

# Thommen Medical AG Special 510(k): Device Modification

# SPI® VARIOmulti Angled Abutment

Orlando Antunes

## ADMINISTRATIVE INFORMATION

Manufacturer Name:

Thommen Medical AG Hauptstrasse 26d CH-4437 Waldenburg, Switzerland Telephone: [phone] Fax: [phone]

Official Contact:

Representative/Consultant:

Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: [phone] Fax: [phone] email: lschulz(@paxmed.com [e-mail]

## DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Product Code: Classification Panel: Reviewing Branch:

SPI® VARIOmulti Angled Abutment Dental implant abutment Endosseous dental implant abutment 21 CFR 872.3630, Class II NHA Dental Products Panel Dental Devices Branch

#### INTENDED USE

Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.

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

## DEVICE DESCRIPTION

SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SP10 Dental Implant System. They have an internal connection to the implant and an external hex prosthetic attachment, and are used for multi-unit, screw-retained, prefabricated restorations. The system includes dedicated prosthetic components.

#### EQUIVALENCE TO MARKETED PRODUCT

Thommen Medical AG demonstrated that, for the purposes of FDA's regulation of medical devices, the SPT® VARIOmulti Angled Abutments are substantially equivalent in indications and design principles to predicate devices that have been determined by FDA to be substantially equivalent to preamendment devices.

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.

Public Health Service

MAR 2 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thommen Medical, AG C/o Ms. Linda K. Schulz, RDH, BSDH PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K090153

> Trade/Device Name: SPI® VARIOmulti Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 20, 2009 Received: January 22, 2009

Dear Ms. Schulz:

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-ffor 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. Schulz

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Suita y. Michael O.m.d.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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

SPI® VARIOmulti Angled Abutment

510(k) Summary

# Indications for Use

510(k) Number (if known); K0910153

Device Name:

SPI® VARIOmulti Angled Abutment

Indications for Use:

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

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)

Susan Punner

Page 1 of

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

510(k) Number: k80063