ASTRA TECH IMPLANT DENTAL SYSTEM

K974738 · Astra Tech, Inc. · DZE · Nov 19, 1998 · Dental

Device Facts

• Record ID: K974738
• Device Name: ASTRA TECH IMPLANT DENTAL SYSTEM
• Applicant: Astra Tech, Inc.
• Product Code: DZE · Dental
• Decision Date: Nov 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

For use in selected fully edentulous and partially edentulous arches. The following table describes the indication for use for each component listed as part of this 510(k) submission: Profile UniAbutment 4.5: Prepable component that is placed in fixture for cemented bridge construction; Profile UniAbutment 5.5 ultra: Prepable component that is placed in fixture for cemented bridge construction; Profile UniAbutment 5.5: Prepable component that is placed in fixture for cemented bridge construction; Profile UniAbutment 7.0: Prepable component that is placed in fixture for cemented bridge construction; Profile BiAbutment 4.5: Prepable component that is placed in fixture for cemented bridge construction; Profile BiAbutment 5.5 ultra: Prepable component that is placed in fixture for cemented bridge construction; Profile BiAbutment 5.5: Prepable component that is placed in fixture for cemented bridge construction; Profile BiAbutment 7.0: Prepable component that is placed in fixture for cemented bridge construction; Profile BiAbutment ST 4.5: Prepable component that is placed in fixture for cemented bridge construction; Profile BiAbutment ST 5.5: Prepable component that is placed in fixture for cemented bridge construction; Profile BiAbutment ST 7.0: Prepable component that is placed in fixture for cemented bridge construction; Abutment Screw ST, short: Screw that is used to attach the Profile BiAbutment ST to the fixture.

Device Story

Prepable Abutment System consists of dental prosthetic components (abutments and screws) for single or multiple tooth constructions; used in conjunction with dental fixtures in edentulous or partially edentulous patients; components are manually placed by clinicians during restorative dental procedures; system facilitates cemented bridge construction; provides structural interface between dental implant fixture and prosthetic restoration; benefits patient by restoring dental function and aesthetics.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate devices.

Technological Characteristics

Commercially pure titanium construction; mechanical dental prosthetic components; includes prepable abutments and attachment screws; designed for integration with dental fixtures; non-electronic; no software.

Indications for Use

Indicated for use in fully or partially edentulous patients requiring cemented bridge construction via dental implants.

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 (Abutment Screw ST, Healing Abutment, Angled Abutment Adapter) (K931767)
• Steri-Oss Dental Implants - Esthetic Abutment System
• Steri-Oss Implants Friction Drive Wrench
• Try-In Kit

Submission Summary (Full Text)

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K974738

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

non 1 9 1208

Submitters Information

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

#### Date Prepared

December 16, 1997

#### Name of Device

Astra Tech Implants - Dental System Prepable Abutment System - ADDITIONAL COMPONENTS for single-tooth and multiple tooth constructions.

#### Classification Name

Endossous Implant

#### Predicate Devices

Similar Devices Previously Approved Under K931767 - Astra Tech Implants - Dental System (Abutment Screw ST, Healing Abutment, Angled Abutment Adapter) Steri-Oss Dental Implants - Esthetic Abutment System, Steri-Oss Implants Friction Drive Wrench, Try-In Kit

#### Description of Device and Intended Use

The Prepable Abutment System is comprised of a selection of components for prosthetic and laboratory procedures for single-tooth and multiple tooth constructions. The additional components provided for by this 510(k) are added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. All implants are made from commercially pure titanium. The indications and uses for these additional components are not different from similar components of the predicate device.

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મેર

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# Nov 1 9 1998

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

Re : K974738 Astra Tech Implants - Dental System Trade Name: Requlatory Class: III Product Code: DZE Dated: September 22, 1998 Received: September 23, 1998

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 aqainst 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 requlations 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) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification 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.

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Page 2 - Mr. Lidskog

This letter will allow you to begin marketing your device as first receir #110 million market notification. The FDA described in your sieth, provilence of your device to a legally finding of babbandarice results in a classification for your marketed predicator and the 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 regulation (stic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on Compriation 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.fdag.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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### 510(k) Number (if known): K974738 Device Name: ASTRA TECH IMPLANTS - DENTAL SYSTEM

### Indications for Use:

For use in selected fully edentulous and partially edentulous arches.

The following table describes the indication for use for each component listed as part of this 510(k) submission:

| Component | Part<br>Number | Indication for Use |
|-------------------------------|----------------|-------------------------------------------------------------------------------|
| Profile UniAbutment 4.5 | 22852 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 5.5 ultra | 22855 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 5.5 | 22856 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 7.0 | 22860 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 4.5 | 22782 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 5.5 ultra | 22785 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 5.5 | 22786 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 7.0 | 22790 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 4.5 | 22870 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 5.5 | 22872 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 7.0 | 22874 | Prepable component that is placed in fixture for cemented bridge construction |
| Abutment Screw ST, short | 22554 | Screw that is used to attach the Profile BiAbutment ST to the fixture |

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------|-------------------------|
| Prescription Line | <span></span> |
| (Per 21 CFR 801.1091) | |
| (Optional format 1-2-9G) | |
| | or Over-the Counter Use |
| (Division Sign-Off) | Susan Dater |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K974738 |