ASTRA TECH IMPLANTS - DENTAL SYSTEM

K980698 · Astra Tech, Inc. · DZE · Mar 19, 1998 · Dental

Device Facts

• Record ID: K980698
• Device Name: ASTRA TECH IMPLANTS - DENTAL SYSTEM
• Applicant: Astra Tech, Inc.
• Product Code: DZE · Dental
• Decision Date: Mar 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

For use in cement retained crown and bridge construction. The following table describes the indication for use for each component listed as part of this 510(k) submission: Cast-to Abutment 3.5 (22827): Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin. Cast-to Abutment 4.0 (22828): Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin. Cast-to Abutment ST (22829): Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin. Abutment Screw, Ultra-gold (sterile) (22838): Attachment element for connection/fixation of abutments to fixtures. Abutment Screw, ST- gold (sterile) (22839): Attachment element for connection/fixation of abutments to fixtures.

Device Story

Astra Tech Implants additional components include gold alloy Cast-to Abutments and gold alloy Abutment Screws; used as base for customized abutment post construction in cement-retained crown and bridge dental procedures; allows compensation for poorly aligned fixtures and adjustment of crown margin position/esthetics; screws serve as attachment elements for fixture-abutment fixation; used by dental professionals in clinical settings; components integrate into existing Astra Tech Dental Implant System.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Gold alloy. Components: Cast-to abutments (diameters 4.5mm, 5.5mm) and gold abutment screws (diameter 2.6mm). Function: Mechanical attachment and customized post base. Sterilization: Provided sterile.

Indications for Use

Indicated for patients requiring cement-retained crown and bridge dental restorations, specifically for the construction of customized abutment posts to compensate for fixture misalignment and address esthetic margin positioning.

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)
• STERI-OSS REPLACE Direct Abutment 5.0 Series

Submission Summary (Full Text)

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Ka806ax

MAR 1 9 1998

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

### Submitters Information

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

## Date Prepared

February 20, 1998

### Name of Device

Astra Tech Implants - Dental System Cast-to Abutment, Cast-to Abutment ST and Abutment Screws- Gold - are ADDITIONAL COMPONENTS for cement retained crown and bridge constructions

#### Classification Name

Endosseous Implant

#### Predicate Devices

Similar Devices Previously Approved Under K931767 - Astra Tech Implants - Dental System (Abutment Screw ST) STERI-OSS REPLACE Direct Abutment 5.0 Series

## Description of Device and Intended Use

Cast-to Abutment, Cast-to Abutment ST and Abutment Screws- Gold - are ADDITIONAL COMPONENTS to the Astra Tech Dental Implant System.

The Cast-to abutments are manufactured in gold alloy and are used as a base for castto customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin.

The Abutment Screws are manufactured in gold alloy and are attachment elements for connection/fixation of abutments to fixtures.

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## List of Components

(

| Product | Diameter<br>(mm) | Part Number |
|----------------------------------------|------------------|-------------|
| Cast-to Abutment 3.5 | 4.5 | 22827 |
| Cast-to Abutment 4.0 | 4.5 | 22828 |
| Cast-to Abutment ST | 5.5 | 22829 |
| Abutment Screw Ultra-gold<br>(Sterile) | 2.6 | 22838 |
| Abutment Screw ST-gold<br>(Sterile) | 2.6 | 22839 |

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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 the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, abstract style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1998

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

Re : K980698 Astra Tech Implants - Dental System Trade Name: Regulatory Class: III Product Code: DZE Dated: February 20, 1998 February 23, 1998 Received:

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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Regulations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as-set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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Page 2 - Mr. Lidskog

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

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.qov/cdrh/dsma/dsmamaim.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

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18069 510(k) Number(if known): Device Name: ASTRA TECH IMPLANTS - DENTAL SYSTEM

Indications for Use:

For use in cement retained crown and bridge construction.

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

| | Part | |
|------------------------------------------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Component | Number | Indication for Use |
| Cast-to Abutment 3.5 | 22827 | Used as a base for cast-to customized abutment post construction.<br>Allowing for compensation of poorly aligned fixtures and for meeting<br>esthetic demands for design and position of the crown margin. |
| Cast-to Abutment 4.0 | 22828 | Used as a base for cast-to customized abutment post construction.<br>Allowing for compensation of poorly aligned fixtures and for meeting<br>esthetic demands for design and position of the crown margin. |
| Cast-to Abutment ST | 22829 | Used as a base for cast-to customized abutment post construction.<br>Allowing for compensation of poorly aligned fixtures and for meeting<br>esthetic demands for design and position of the crown margin. |
| Abutment Screw, Ultra-<br>gold (sterile) | 22838 | Attachment element for connection/fixation of abutments to fixtures |
| Abutment Screw, ST- gold<br>(sterile) | 22839 | Attachment element for connection/fixation of abutments to fixtures |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

0 M Prescription Line ... or (Per 21 CFR 801.1091) (Optional format 1-2-9G)

... Over-the-Counter-Use . . . .......

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Sumner

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

K>20698