SPI SYSTEM DENTAL IMPLANTS

K072649 · Thommen Medical AG · DZE · Dec 6, 2007 · Dental

Device Facts

• Record ID: K072649
• Device Name: SPI SYSTEM DENTAL IMPLANTS
• Applicant: Thommen Medical AG
• Product Code: DZE · Dental
• Decision Date: Dec 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SPI® System Dental Implants are for one-stage or two-stage surgical procedures. SPI System Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Device Story

SPI System Dental Implants are self-tapping, root-form, endosseous dental implants; manufactured from commercially pure grade titanium. Used by dental surgeons in clinical settings for one-stage or two-stage surgical procedures. Implants provide foundation for single or multiple tooth restorations; restore chewing function. Device allows for immediate functional loading when primary stability is achieved; supports reduced six-week healing protocol compared to conventional twelve-week standards. Clinical benefit includes faster restoration of dental function for patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on design principles and intended use.

Technological Characteristics

Self-tapping, root-form, endosseous dental implants; material: commercially pure grade titanium. Dimensions: includes 3.5 mm diameter variants. Sterilization: not specified. Connectivity: N/A. Software: N/A.

Indications for Use

Indicated for one-stage or two-stage surgical procedures for single or multiple tooth replacement to restore chewing function. Suitable for immediate placement and function when primary stability is achieved and occlusal loading is appropriate. Edentulous patients require four or more implants for immediate loading. Contraindicated for 3.5mm diameter ELEMENT and CONTACT implants in areas with high rotation/translation (bending) forces, specifically: posterior teeth in upper/lower jaw, single-tooth restoration of upper canines/central incisors, and applications involving retentive anchors.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Submission Summary (Full Text)

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510(k) Summary

K072649

SPI® System Dental Implants

# 510(k) Summary

## Thommen Medical AG SPI® System Dental Implants

#### 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: Common Name: Classification Regulations:

Product Codes Classification Panel: Reviewing Branch:

SPI® System Dental Implants Dental implant Endosseous dental implant 21 CFR 872.3640, Class II DZE Dental Products Panel Dental Devices Branch

#### INTENDED USE

SPI® System Dental Implants are for one-stage or two-stage surgical procedures. SPI System Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

DEC # 6 2007

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K072649

SPI® System Dental Implants

Contraindications for the use of SP1® ELEMENT implant Ø 3.5 mm and SP1® CONTACT implant Ø 3.5 mm:

These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.

- Restoration of posterior teeth in the upper and lower jaw -
- Single-tooth restoration of canines and central incisors in the upper jaw -
- Any application involving retentive anchors -

#### DEVICE DESCRIPTION

Thommen SPI Dental Implants are self tapping, root form, endosseous dental implants made of commercially pure grade titanium. The intended use of the subject endosseous dental implants includes a six week healing period when conventional loading protocols are used, rather than the currently recommended twelve-week minimum healing period, as well as to permit immediate functional loading of single-tooth or multiple unit restorations when good primary stability is achieved.

#### EQUIVALENCE TO MARKETED PRODUCT

Thommen Medical AG has demonstrated that, for the purposes of FDA's regulation of medical devices, the SPI System Dental Implants are substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 6 2007

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

Rc: K072649

Trade/Device Name: SPI® System Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 29, 2007 Received: November 30, 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 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,

Suite of Michigan Dms.

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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510(k) Premarket Notification

K072649

SPI® System Dental Implants

18/1

### Indications for Use

510(k) Number (if known):

SPI® System Dental Implants Device Name:

Indications for Use:

SPI® System Dental Implants are for one-stage or two-stage surgical procedures. SPI System Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Contraindications for the use of SP1® ELEMENT implant Ø 3.5 mm and SPT® CONTACT implant Ø 3.5 mm:

These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.

- Restoration of posterior teeth in the upper and lower jaw -
- -Single-tooth restoration of canines and central incisors in the upper jaw
- Any application involving retentive anchors. -

Suen (Kusner

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

510(k) Number: K072649

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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