SPI CUSTOMIZABLE GINGIVA FORMER

K092248 · Thommen Medical AG · NHA · Sep 25, 2009 · Dental

Device Facts

• Record ID: K092248
• Device Name: SPI CUSTOMIZABLE GINGIVA FORMER
• Applicant: Thommen Medical AG
• Product Code: NHA · Dental
• Decision Date: Sep 25, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.

Device Story

SPI® Customizable Gingiva Former is a temporary endosseous dental implant component; used to maintain gingival contour and serve as a base for temporary restoration fabrication. Device consists of an acrylic-based polymer body with a titanium base for interface with SPI® System dental implants. Used in dental clinics by clinicians; provides temporary support for crowns or bridges. Benefits include stable connection and gingival tissue management during the healing phase prior to final restoration.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Acrylic-based polymer and titanium base. Form factor: Endosseous dental implant abutment. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients requiring temporary support for crowns or bridges in the maxillary or mandibular arch in conjunction with 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.)

Predicate Devices

• K051527
• K033346
• K023645
• K031747

Submission Summary (Full Text)

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510(k) Summary

# REVISED 510(k) Summary

Ko92248

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

SPI® Customizable Gingiva Former

SEP 2 5 2009

# ADMINISTRATIVE INFORMATION

Manufacturer Name

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

Official Contact:

Orlando Antunes

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: [e-mail] [e-mail]

### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | SPI® Customizable Gingiva Former |
|------------------------------------|--------------------------------------------------------------------|
| Common Name: | Endosseous dental implant abutment |
| Classification Regulations: | Abutment, Implant, Dental, Endosseous<br>21 CFR 872.3630, Class II |
| Product Code: | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
| Establishment Registration Number: | 3003836985 |
| Owner/Operator Number: | 9051144 |

#### INTENDED USE

The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.

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## DEVICE DESCRIPTION

The Thommen SPI® Customizable Gingiva Former is a temporary endosseous dental implant component made from an acrylic-based polymer with a titanium base at the implant/abutment interface for a stable, precise connection. The SPT® Customizable Gingiva Former is used for maintaining gingival contour and as a base for fabrication of a temporary restoration.

## EQUIVALENCE TO MARKETED PRODUCT

Predicate devices: K051527, K033346, K023645 and K031747.

The SPI® Customizable Gingiva Former has the following similarities to the unmodified predicate devices:

- · has the same intended use,
- · uses the same operating principle,
- · uses the same or similar materials
- · incorporates the same basic design, and
- · is packaged using the same materials and processes.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

SEP 2 5 LUUS

Thommen Medical, AG C/O Ms. Linda K. Schulz Regulatory Affairs Specialist PaxMed Interational, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K092248

Trade/Device Name: SPI® Customizable Gingiva Former Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 17, 2009 Received: September 18, 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 (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 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 i Register.

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#### 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 promarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

R. Un for

Susan Runner, D.D.S., M.A. Acting Division 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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# REVISED Indications for Use

Applicant: Thommen Medical AG

510(k) Number (if known):

Device Name: SPI® Customizable Gingiva Former

Indications for Use:

The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPT® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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 Muluy for MSP

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

510(k) Number: