SPI ELEMENT PLATFORM O 4.0 MM

K070007 · Thommen Medical AG · DZE · Jan 10, 2007 · Dental

Device Facts

• Record ID: K070007
• Device Name: SPI ELEMENT PLATFORM O 4.0 MM
• Applicant: Thommen Medical AG
• Product Code: DZE · Dental
• Decision Date: Jan 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thommen SPI® ELEMENT Dental Implant is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures, SPI® Dental Implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.

Device Story

Root-form endosseous dental implant; surgically placed in maxillary or mandibular bone; provides support for dental prosthetics (crowns, bridges, overdentures). Implant features smooth machined transgingival portion and sandblasted/acid-etched bone-contacting surface. Used by dental professionals in clinical settings. Immediate loading possible under specific splinting conditions. Benefits include restoration of dental function and aesthetics.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and process similarities to predicate.

Technological Characteristics

Commercially pure grade 4 titanium; ASTM F 67 and ISO 5832-2 compliant. Root-form geometry; 4.0 mm platform diameter. Surface treatment: sandblasted and acid-etched. Sterilization: Co60 gamma irradiation (25 kGy).

Indications for Use

Indicated for patients requiring dental implants in the maxillary or mandibular arch for support of crowns, bridges, or overdentures. Can be placed post-extraction or post-healing. Immediate loading permitted only if splinted with a bar (4 implants mandibular, 6 implants maxillary).

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.

Predicate Devices

• SPI® ELEMENT Dental Implant (K070007)

Submission Summary (Full Text)

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Ko70007

# 510(k) Summary

JAN 1 0 2007

# Special 510(k): Device Modification

# SPI® ELEMENT Platform Ø 4.0 mm

#### ADMINISTRATIVE INFORMATION

Sponsor Name: Thommen Medical AG I-aupstrasse 26d CH-4437 Waldenburg, Switzerland Telephone: [phone] Fax: [phone] Official Contact: Orlando Antunes Representative/Consultant: Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone [phone] Fax [phone]

#### DEVICE NAME

Classification Name:

Trade/Proprietary Name: Common Name:

Implant, Endosseous, Root-Form Abutment, Implant, Dental, Endosseous SPI® ELEMENT Platform Ø 4.0 mm Dental implant

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 and abutments as Class II devices (21 CFR 872.3640 and 21 CFR 872.3630). The product code for Implant, Endosseous, Root-Form is DZE and the product code for "Abutment, Implant, Dental, Endosseous" is NHA.

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### INTENDED USE

The Thommen SPI® ELEMENT Dental Implant is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures, SPI® Dental Implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.

#### CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards applicable to endosseous dental implants have been established by FDA. The SPI ELEMENT dental implants meet the chemical requirements of ASTM F 67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) and ISO 5832-2 Implants for surgery --Metallic materials -- Part 2: Unalloved titanium.

#### DEVICE DESCRIPTION

The Thommen SPI® ELEMENT Platform Ø 4.0 mm is a root form endosseous dental implant made of commercially pure grade 4 titanium. The implant surface is smooth machined on the transgingival portion and sandblasted and acid-etched in the area designed to contact bone.

### PACKAGING/LABELING/PRODUCT INFORMATION

Thommen SPI® ELEMENT Platform Ø 4.0 mm will be packaged in a radiation sterilizable package consisting of a primary container, with implant and auxiliary parts, sealed with a peel-off wrapping. Sterilization will be accomplished by means of Co " gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad).

#### EQUIVALENCE TO MARKETED PRODUCT

The SP1® ELEMENT Platform Ø 4.0 mm has the following similarities to the predicate SP10 ELEMENT Dental Implant:

- · has the same intended use.
- · uses the same operating principle,
- · incorporates the same basic design, (with the addition of a new platform diameter),
- · incorporates the same materials, and
- · is packaged and sterilized using the same materials and processes.

In summary, the Thommen SPI® ELEMENT Platform Ø 4.0 mm described in this submission is, in our opinion, substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design, possibly representing a human figure or a symbol of care and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the design, indicating the organization's name and country.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 2 2009 נוע

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

Re: K070007

Trade/Device Name: SPI® ELEMENT Platform Ø 4.0 mm Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 29, 2006 Received: January 3, 2007

Dear Mr. Larson:

This letter corrects our substantially equivalent letter of January 10, 2007.

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 (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 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); 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 premarket 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,

Susan Purner

Susan Runner, D.D.S., MA

Acting 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

K070007

510(k) Number (if known):

SPI® ELEMENT Platform Ø 4.0 mm

Device Name:

Indications for Use:

The Thommen SPI® ELEMENT Dental Implant is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental Implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.

Prescription Use 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)

Susa Russo

of Anesthesiology, General Hospical, on Control, Dental Devices

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