SPI EASY 4.0 ABUTMENT

K071453 · Thommen Medical AG · NHA · Sep 19, 2007 · Dental

Device Facts

• Record ID: K071453
• Device Name: SPI EASY 4.0 ABUTMENT
• Applicant: Thommen Medical AG
• Product Code: NHA · Dental
• Decision Date: Sep 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Thommen SPI® EASY Ø 4.0 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.

Device Story

The SPI® EASY Ø 4.0 Abutment is a dental implant component designed to interface with SPI® System dental implants. It serves as an intermediary connector between the endosseous implant and the final dental restoration (crown, bridge, or overdenture). The device is used by dental professionals in a clinical setting to provide structural support for prosthetic teeth. It functions as a mechanical attachment, ensuring stability and proper alignment of the restoration within the patient's jaw. By facilitating the connection between the implant and the prosthesis, it enables the restoration of oral function and aesthetics for patients with missing teeth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental implant abutment; metallic construction consistent with SPI System components; designed for 4.0 platform interface; mechanical connection to endosseous dental implants.

Indications for Use

Indicated for patients requiring dental implant-supported restorations (crowns, bridges, or overdentures) in the maxillary or mandibular arch using the SPI® System.

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 EASY Dental Implant Abutment (K071453)

Submission Summary (Full Text)

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SPI® EASY Ø 4.0 Abutment

# 510(k) Summary

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

# SEF 1 9 2007

# SPI® EASY Ø 4.0 Abutment

### ADMINISTRATIVE INFORMATION

Manufacturer Name:

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

Official Contact:

Representative/Consultant:

Orlando Antunes

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: Common Name: Classification Name:

Product Code Classification Panel: Reviewing Branch:

SPI® EASY Ø 4.0 Abutment Dental implant abutment Abutment, Implant, Dental, Endosseous (21 CFR 872.3640), 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

The Thommen SPI® EASY Ø 4.0 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.

## DEVICE DESCRIPTION

The design of the SPI EASY Abutment System has been modified to add additional abutments to fit the 4.0 platform components.

# EQUIVALENCE TO MARKETED PRODUCT

The SPI EASY Ø 4.0 Abutment has the following similarities to the unmodified predicate SPI EASY Dental Implant Abutment:

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

SEP 1 9 2007

Re: K071453

Trade/Device Name: SPI® EASYØ 4.0 Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 22, 2007 Received: August 23, 2007

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 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 - 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 (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.

Syndie Y. Michael Davis

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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# Indications for Use

Applicant:

Thommen Medical AG

510(k) Number (if known): K071453

SPI® EASY Ø 4.0 Abutment Device Name:

Indications for Use:

The Thommen SPI® EASY Ø 4.0 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.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(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)


(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

| 510(k) Number: | 1671453 |
|----------------|---------|
|----------------|---------|

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