MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM

K990304 · Astra Tech, Inc. · DZE · Jul 15, 1999 · Dental

Device Facts

• Record ID: K990304
• Device Name: MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM
• Applicant: Astra Tech, Inc.
• Product Code: DZE · Dental
• Decision Date: Jul 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in selected fully edentulous and partially edentulous arches

Device Story

Astra Tech Implants Dental System consists of root-form, uncoated, commercially pure titanium screws (fixtures) and associated abutments. These components are used in dental surgery to replace missing teeth in partially or totally edentulous patients. The system supports single-tooth and multiple-tooth construction clinical situations. The device is used by dental clinicians in a clinical setting. The implants are surgically placed into the jawbone to provide a stable foundation for prosthetic restorations, benefiting patients by restoring dental function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Root-form, uncoated screws; material: commercially pure titanium; dimensions vary by part number (diameters/lengths/cuffs specified); mechanical fixation; non-sterile (implants typically sterilized by user); no software or electronic components.

Indications for Use

Indicated for use in selected fully edentulous and partially edentulous arches for dental restoration.

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

• Astra Tech Implants - Dental System (K931767)

Submission Summary (Full Text)

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K990304

JUL 15 1999

## 510(k) SUMMARY Astra Tech Implants Dental System Additional Components

#### Submitters Information

Astra Tech, Inc. 430 Bedford Street, Suite 100 Lexington, MA 02173 781-861-7707 Contact: Mr. Niklas Lidskog

#### Date Prepared

January 12, 1999

#### Name of Device

Astra Tech Implants - Dental System Additional Abutments and Fixtures for Single Tooth Implant and Standard Implant

#### Classification Name

Endosseous Implant

#### Predicate Devices

Similar Devices Previously Approved Under K931767 - Astra Tech Implants - Dental System

### Description of Device and Intended Use

The additional components provided for by this 510(k) added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. All implants are root-form uncoated screws and are made from commercially pure titanium. The indications and uses for these additional components are not different from similar components of the predicate device. The application also provides for the use of the Single Tooth Implant System in multiple construction clinical situations.

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# List of Components

| Product | Diameter | Part Number |
|---------------------|-------------------|-------------|
| Uni Abutment | Ultrashort, 20 mm | 22388 |
| Uni Abutment | Ultrashort, 45 mm | 22389 |
| Healing Abutment ST | Short | 22586 |
| Healing Abutment ST | Intermediate | 22589 |
| Abutment Screw ST | Short | 22554 |
| Uni Abutment ST | 20, 0.0 mm Cuff | 22674 |
| Uni Abutment ST | 20, 1.5 mm Cuff | 22675 |
| Uni Abutment ST | 20, 3.0 mm Cuff | 22676 |
| Uni Abutment ST | 20, 4.5 mm Cuff | 22677 |
| Uni Abutment ST | 20, 6.0 mm Cuff | 22678 |
| Uni Abutment ST | 45, 0.0 mm Cuff | 22694 |
| Uni Abutment ST | 45, 1.5 mm Cuff | 22695 |
| Uni Abutment ST | 45, 3.0 mm Cuff | 22696 |
| Uni Abutment ST | 45, 4.5 mm Cuff | 22697 |
| Uni Abutment ST | 45, 6.0 mm Cuff | 22698 |
| Fixture ST | 5.0 mm x 9 mm | 22821 |
| Fixture ST | 5.0 mm x 11 mm | 22822 |
| Fixture ST | 5.0 mm x 13 mm | 22823 |
| Fixture ST | 5.0 mm x 15 mm | 22824 |
| Fixture ST | 5.0 mm x 17 mm | 22825 |
| Fixture ST | 5.0 mm x 19 mm | 22826 |
| Fixture ST | 3.5/4.5, 9 mm | 22209 |
| Fixture ST | 3.5/4.5, 9 mm | 22212 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 1999

Mr. Niklas Lidskog Astra Tech, Incorporated 430 Bedford Street, Suite 100 Lexington, Massachusetts 02173

Re : K990304 Modification To Astra Tech Implants - Dental Trade Name: System Regulatory Class: III Product Code: DZE Dated: May 13, 1999 Received: May 17, 1999

Dear Mr. Lidskog:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lidskog

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Not Known 1990304 510(k) Number (if known): Astra Tech Implants - Dental System Device Name: For use in selected fully edentulous and partially Indications for Use: edentulous arches

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Line V (Per 21 CFR 801.1091

or

Over-The-Counter Use

(Optional Format 1-2-9G)

Susan Purrs

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices () { } 510(k) Number _