SPI DENTAL IMPLANT ABUTMENTS

K031747 · Thommen Medical AG · NHA · Jul 2, 2003 · Dental

Device Facts

• Record ID: K031747
• Device Name: SPI DENTAL IMPLANT ABUTMENTS
• Applicant: Thommen Medical AG
• Product Code: NHA · Dental
• Decision Date: Jul 2, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Thommen SPI® Dental Implant 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.

Device Story

SPI Dental Implant Abutments are endosseous components used in conjunction with SPI System dental implants; provide support for cemented single crowns, bridges, or overdentures. Device fabricated from commercially pure grade titanium; intended for use in maxillary and/or mandibular arches. Operated by dental professionals in clinical settings. Device serves as interface between endosseous implant and prosthetic restoration; facilitates functional and aesthetic dental rehabilitation. Sold non-sterile.

Clinical Evidence

No clinical data. Substantial equivalence based on design, material, and intended use comparisons to predicate devices.

Technological Characteristics

Commercially pure titanium (Grade 4) meeting ASTM F67 and ISO 5832-2. Endosseous dental implant abutment form factor. Non-sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring dental restoration in the maxillary or mandibular arch using SPI System dental implants to support crowns, bridges, or overdentures.

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

• HA-Ti Dental Implant System (K901927)
• SPI Easy Dental Implant Abutment (K023645)

Submission Summary (Full Text)

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| ADMINISTRATIVE INFORMATION | JUL 2 2003 | K031747 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer Name: | Thommen Medical AG<br>Hauptstrasse 87<br>CH-4437 Waldenburg<br>Switzerland<br>Telephone [phone]<br>FAX [phone] | JUL 2 2003 |
| Official Contact: | Orlando Antunes | |
| Representative/Consultant: | Floyd G. Larson<br>PaxMed International<br>4329 Graydon Road<br>San Diego, CA 92130<br>Telephone [phone]<br>FAX [phone] | |
| DEVICE NAME | | |
| Classification Name: | Abutment, Implant, Dental, Endosseous (NHA) | |
| Trade/Proprietary Name: | SPI® Dental Implant Abutments | |
| Common Name: | Endosseous Dental Implant Abutment | |

# ESTABLISHMENT REGISTRATION NUMBER

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

## DEVICE CLASSIFICATION

FDA has classified endosseous dental implants as a Class III device (21 CFR 872.3640). The product code for "Abutment, Implant, Dental, Endosseous" is NHA.

#### CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards applicable to endosseous dental implant abutments have been established by FDA. However, CP titanium Grade 4 used to manufacture Thommen dental implant abutments meets the chemical and mechanical requirements of ASTM F67 and ISO 5832-2.

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# PREDICATE DEVICE INFORMATION

The predicate devices for this modification are the HA-Ti Dental Implant System, cleared by FDA on January 4, 1991 under K901927 and SPI Easy Dental Implant Abutment (Thommen A.G.), cleared on November 13, 2002 under K023645, Thommen Medical AG has acquired the rights to the HA-Ti Dental Implant System from HATI Dental and has renamed it the SPI® System.

#### PACKAGING/LABELING/PRODUCT INFORMATION

Thommen SPI® Dental Implant Abutments will be packaged and sold non-sterile. The device is not represented to be "pyroqen free. All cataloques will be amended to include the modified devices, consistent with the information shown for existing devices.

#### INTENDED USE

Thommen SPI® Dental Implant 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.

# DEVICE DESCRIPTION

Thommen SP1® Dental Implant Abutments are endosseous dental implant abutments made of commercially pure grade titanium and intended for cemented restorations. They may be used for cemented single crowns or bridges.

# EQUIVALENCE TO MARKETED PRODUCT

The modified SPI® Dental Implant Abutments have the following similarities to the predicate HA-Ti Dental Implant Abutment and Thommen SP1® Dental Implant 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 modified Thommen SP1® Dental Implant Abutments described in this submission are, in our opinion, substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2003

Thommen Medical, AG C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130

Re: K031747

Trade/Device Name: SPI Dental Implant Abutment Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: June 3, 2003 Received: June 5, 2003

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 (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 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 vours.

Suser Runre

Susan Runner, DDS, MA Interim 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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Applicant: Thommen Medical AG

510(k) Number:

Device Name: SPI® Dental Implant Abutment

Indications for Use:

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

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510(k) Number: K031741 iv