ASTRA TECH IMPLANTS - DENTAL SYSTEM

K041492 · Astra Tech, Inc. · DZE · Aug 9, 2004 · Dental

Device Facts

• Record ID: K041492
• Device Name: ASTRA TECH IMPLANTS - DENTAL SYSTEM
• Applicant: Astra Tech, Inc.
• Product Code: DZE · Dental
• Decision Date: Aug 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This application provides for revision of Astra Tech Dental Implants labeling allowing the option of immediate function. The intended use for this device is to provide support for prosthetic constructions for fully and partially edentulous arches using one or two stage surgical procedures.

Device Story

Astra Tech Dental Implants are root-formed threaded screws composed of commercially pure titanium. Device provides support for prosthetic constructions in fully or partially edentulous arches. Used in single or two-stage surgical procedures. Allows for immediate placement and function on single or multiple tooth applications, provided patient has sufficient bone stability (type I or II) and appropriate occlusal loading. Multiple tooth applications may be splinted with a bar. Device is used by dental professionals in a clinical setting to restore chewing function. Output is the physical implant structure which serves as an anchor for dental restorations. Clinical benefit is the restoration of chewing function through immediate loading.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design similarities and technological characteristics identical to the predicate device.

Technological Characteristics

Root-formed threaded screws; material: commercially pure titanium; single or two-stage surgical application; intended for immediate or delayed loading; no changes to physical design or materials from previous versions.

Indications for Use

Indicated for single-stage or two-stage surgical procedures and cement or screw retained restorations. Intended for immediate placement and function on single or multiple tooth applications in patients with sufficient bone stability (type I or II bone) and appropriate occlusal loading to restore chewing function. Multiple tooth applications may be splinted with a bar.

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

• Brånemark System Dental Implant (K022562)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG - 9 2004

K041492

## 510(k) SUMMARY

# Astra Tech Implants Dental System Immediate Function

### Submitters Information

| Submitter's Name: | Astra Tech, Inc. |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Adress: | (US Representative)<br>Astra Tech Inc.<br>890 Winter Street, Suite 310<br>Waltham, MA 02451-1493<br>781-890-6800 phone<br>781-890-6808 fax |
| Contact's names and<br>Telephone numbers: | Niklas Lidskog, President, 781-890-6800<br>Ann-Mari Eriksson, Manager Regulatory Affairs<br>[phone].<br>Bruce Manning, Consultant, New England<br>Biomedical Research, 508-393-3100 |
| Date Prepared: | May 2004 |
| Address (Manufacturer) | Astra Tech AB<br>P.O Box 14<br>SE-431-21 Mölndal<br>Sweden |
| Device name | |
| Proprietary name: | Astra Tech Implants-Dental System, Immediate<br>function |
| Common name: | Dental implant |
| Classification name: | Endosseous Dental Implant |

{1}------------------------------------------------

#### Identification of legally market dev

Various Brånemark System Dental Implant products, submitted by Nobel BioCare under 510(k) K022562

#### Description of Device

The Astra Tech Dental Implants are root-formed threaded screws made from commercially pure titanium.

The indications and use for the components are not different from similar components of the predicate device.

#### Intended Use

This application provides for revision of Astra Tech Dental Implants labeling allowing the option of immediate function. The intended use for this device is to provide support for prosthetic constructions for fully and partially edentulous arches using one or two stage

# surgical procedures.

#### Indications for use

The Astra Tech Implants - Dental System are for single-stage or twosurgical procedures and cement or screw retained restorations. The The Astra Tech Implants - Dental System are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

#### Comparison of technological characteristics.

The technological characteristics of the Astra Tech Dental Implants remain unchanged. This application does only provide for a change in labeling allowi the option of immediate function.

Substantial equivalence of the Astra Tech Dental Implants is based on design similarities between the predicate device and the device in this application. The proposed and the predicate device are very similar in terms of material, size and basic design.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal. The seal is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2004

Astra Tech, Incorporated C/O Mr. Bruce R. Manning New England Biomedical Research, Incorporated 96 West Main Street P.O. Box 809 Northborough, Massachusetts 01532

Re: K041492

Trade/Device Name: Astra Tech Implants - Dental System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 3, 2004 Received: June 4, 2004

Dear Mr. Manning:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo may referenced above and have determined the device is substantially equivalent (for the icreicheco above and nave determinoure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device microlate commerce prior to tray as been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the I cueral I vou, Drag, and Sobu may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include confrols providents of a 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 such additional controls. Existing major regulations affecting (1 Mr), it may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device oan or roundsh further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. Manning

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualled on that your device complies with other requirements mean that FDA has made a decermination that your has your within Federal agencies. of the Act of ally rederal statutes and regulations, but not limited to: registration You must comply with an the Act 3 requirements and ); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 5 0(k) I his letter will anow you to begin mationing your substantial equivalence of your device to a premarket notification. "The FDA miding or 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), If you desire specific advice for your at [phone]. Also, please note the regulation in prease contact the Other of Ochipsian premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Divisor [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Chiu 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

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Astra Tech Implants - Dental System Device Name:

Indications For Use:

The Astra Tech Implants – Dental System are for single-stage or two-stage surgical The Astra Tech Implants - Dontal System retained restorations. The Astra Tech Implants procedures and ochion of ourself readiate placement and function on single tooth Dental System are intendou for inineous in thines stability (type I or II bone) and/or multiple tooth applications to restore chewing function. Multiple tooth applications may be splinted with a bar.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(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)

Robert S. Betz DDS for Dr. Susan Runner

onv General Hospital

Page 1 of 1

510(k) Number: K041492