SPI ART ABUTMENT

K073141 · Thommen Medical AG · NHA · Dec 5, 2007 · Dental

Device Facts

• Record ID: K073141
• Device Name: SPI ART ABUTMENT
• Applicant: Thommen Medical AG
• Product Code: NHA · Dental
• Decision Date: Dec 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

SPI® ART Abutment is 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 Abutment is contraindicated for free-end bridges or bridges with more than one intermediate pontic element.

Device Story

SPI® ART Abutment is a dental implant abutment used in conjunction with SPI® System dental implants. It serves as an interface between the endosseous implant and the prosthetic restoration (crowns, bridges, or overdentures). The device is used by dental professionals in a clinical setting. It functions as a mechanical support component to secure the prosthesis to the implant. The modification adds abutments to fit 3.5 mm and 4.0 mm platform components. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental implant abutment; metallic construction; designed for 3.5 mm and 4.0 mm platform SPI® System dental implants; mechanical fixation.

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.)

Predicate Devices

• SPI® ART Abutment (K073141)

Submission Summary (Full Text)

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0(k) Summary

SPI® ART Abutment

K073141

# 510(k) Summary

Thommen Medical AG Special 510(k): Device Modification

## SPI® ART Abutment

## ADMINISTRATIVE INFORMATION

DEC 0 5 2007

Manufacturer Name:

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

Official Contact:

Representative/Consultant:

Orlando Antunes

Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: [phone] Fax: [phone] Email: [e-mail]

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Name:

Product Code: Classification Panel: Reviewing Branch:

SPI® ART Abutment Dental implant abutment Abutment, Implant, Dental, Endosseous (21 CFR 872.3630), Class II NHA Dental Products Dental Devices

### ESTABLISHMENT REGISTRATION

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

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510(k) Summary

### INTENDED USE

SPI® ART Abutment is 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 Abutment is contraindicated for free-end bridges or bridges with more than one intermediate pontic element.

#### DEVICE DESCRIPTION

The design of the SPI ART Abutment System has been modified to add additional abutments to fit the 3.5 mm and 4.0 mm platform components.

#### EQUIVALENCE TO MARKETED PRODUCT

The SPI ART Ø 3.5 mm and 4.0 mm abutments have the following similarities to the unmodified predicate SPI ART Abutment:

- · have the same intended use,
- · use the same operating principle,
- · incorporate the same basic design,
- · incorporate the same materials, and
- · are packaged using the same materials and processes.

In summary, the SPI ART Abutment described in this submission is, in our opinion, substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 5 2007

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

Re: K073141

Trade/Device Name: SP1® ART Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 6, 2007 Received: November 7, 2007

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, 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 - 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 yours,

Snytte y. Michie O ins.

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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pecial 510(k): Device Modification

SPI® ART Abutment

## Indications for Use

510(k) Number (if known):

Device Name:

SPI® ART Abutment

Indications for Use:

SPI® ART Abutment is intended to be used in conjunction with SP10 System dental implants in SP1 ART Abulinent is meetica to 60 assume in to provide support for crowns, bridges or overdentures.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|----------------------------------------------|---|
| Over-The-Counter Use (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)


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