SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24

K060376 · Simpler Implant, Inc. · DZE · Apr 25, 2006 · Dental

Device Facts

• Record ID: K060376
• Device Name: SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24
• Applicant: Simpler Implant, Inc.
• Product Code: DZE · Dental
• Decision Date: Apr 25, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Simpler HA Coated Threaded Dental Implants are endosseous threaded implants used as an artificial root structure to replace missing teeth. They are used to support crowns. bridges, or dentures in the maxilla or mandible area of the mouth.

Device Story

Simpler HA Coated Threaded Dental Implants function as artificial root structures for tooth replacement. Implants are surgically placed into the maxilla or mandible to provide support for prosthetic restorations including crowns, bridges, or dentures. Device is intended for use by dental professionals in a clinical setting. Benefit includes restoration of oral function and aesthetics for patients with missing teeth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous threaded dental implant with Hydroxyapatite (HA) coating. Designed for placement in maxilla or mandible. Class II device under 21 CFR 872.3640.

Indications for Use

Indicated for patients requiring replacement of missing teeth in the maxilla or mandible. Used as artificial root structures to support crowns, bridges, or dentures.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2006

Ms. Karen Bergman Simpler Implant, Incorporated 404-1023 Wolfe Avenue Vancouver, British Columbia V6H 1V6 Canada

Re: K060376

Trade/Device Name: Simpler Threaded HA Coated, Models ST 5002-5016, Simpler T Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: April 11, 2006 Received: April 13, 2006

Dear Ms. Bergman:

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 Ms. Karen Bergman

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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Chiu Lin, Ph.D.

Hiu 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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K060376

## VI: INDICATIONS FOR USE

510(k) Number (if known)

Device Name Simpler HA Coated Threaded Dental Impiants

Indications for Use:

The Simpler HA Coated Threaded Dental Implants are endosseous threaded implants used as an artificial root structure to replace missing teeth. They are used to support crowns. bridges, or dentures in the maxilla or mandible area of the mouth.

Please do not write below this line.

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Concurrence of CDRH, Office of Device Evaluation(ODE)

Susan Rower

iology, General Hospital,
ental Devices.

4/5/66 - K06-376

Prescription ( se_ yes Part 21 CFR 801 Subpari D