ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED

K024111 · Astra Tech, Inc. · DZE · Jun 10, 2003 · Dental

Device Facts

• Record ID: K024111
• Device Name: ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED
• Applicant: Astra Tech, Inc.
• Product Code: DZE · Dental
• Decision Date: Jun 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fixture OsseoSpeed and Fixture MicroMacro are intended for endosseous implantation in the mandible and maxilla supporting single-tooth replacements, partial and total fixed/fixed detachable bridges and overdentures. One or two stage surgical procedure can be used. When using the one stage surgical protocol, immediate loading may be applied in the anterior mandibular region (between the mental foramina) if at least four implants are splinted with a bar, or other continuous suprastructure.

Device Story

Root-form threaded dental implants; Grade 4 titanium; machined, grit-blasted, and cleaned. Used for single-tooth replacement, bridges, and overdentures. Placed via one or two-stage surgery in mandible or maxilla. Immediate loading permitted in anterior mandible if splinted with bar/suprastructure. Operated by dental professionals in clinical settings. Output is a stable foundation for dental prosthetics; aids in restoring oral function and aesthetics.

Clinical Evidence

Immediate loading claims supported by clinical data. Bench testing conducted to verify device functionality and design requirements.

Technological Characteristics

Root-form threaded dental implant; Grade 4 titanium; machined, grit-blasted, and cleaned. Diameters 3.5-5.0 mm; lengths 8-19 mm. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring endosseous dental implants in the mandible or maxilla for single-tooth replacement, partial/total fixed bridges, or overdentures. Immediate loading indicated only in the anterior mandible (between mental foramina) using a one-stage surgical protocol with at least four splinted 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 (K931767)
• Astra Tech Implants (K990304)
• Astra Tech Implants (K991053)
• Astra Tech Implants (K002513)
• Astra Tech Implants (K012965)

Submission Summary (Full Text)

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# JUN 1 0 2003

## 510K Summary of Safety and Effectiveness

### Astra Tech Fixture OsseoSpeed Astra Tech Fixture MicroMacro (new indication)

- 1. Sponsor Name:
Astra Tech, Inc. 430 Bedford St. Suite 100 Lexington, MA 02240

- 2. Device Name
Proprietary Names:

Astra Tech Implants - Dental System Fixture OsseoSpeed Astra Tech Implants - Dental System Fixture MicroMacro (new indication)

Common Name: Dental Implant

Classification name: Endosseous Dental Implant (21 CFR 872.3640)

- 3. Identification of Legally Marketed Device
The Fixture OsseoSpeed is substantially similar in intended use, material, and design when compared to implants previously cleared via Astra Tech's 510(k) Numbers K931767, K990304, and K991053. The Fixture OsseoSpeed is considered substantially equivalent to components previously cleared under these 510(k)'s.

The Fixture MicroMacro is a legally marketed device (K991053) that has previously been found to be substantially equivalent to fixtures covered in Astra Tech 510(k) Number K931767. This 510(k) revises its intended use to include one stage surgical procedure and immediate loading situations under conditions previously approved for other Astra Tech fixtures under K002513 and K012965, respectively.

The abutments used with the Fixture OsseoSpeed are equivalent in intended purpose, material, and design compared with the standard abutments cleared via K931767, K974738, and K980698.

- 4. Device Description

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The Fixture OsseoSpeed is a root-form threaded dental implant made of Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.5, 4.0, 4.5 and 5.0 mm. and lengths from 8mm to 19mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delayed.

Fixture MicroMacro is of similar design and construction and is available in diameters 3.5 and 4.0mm, and lengths from 8mm to 19mm.

- ട. Intended Use
The Fixture OsseoSpeed and Fixture MicroMacro are intended for endosseous implantation in the mandible and maxilla supporting single-tooth replacements, partial and total fixed/fixed detachable bridges and overdentures. One or two stage surgical procedure can be used. When using the one stage surgical protocol, immediate loading may be applied in the anterior mandibular region (between the mental foramina) if at least four implants are splinted with a bar, or other continuous suprastructure.

- Comparison of Technological Characteristics 6.
Substantial equivalence of the Fixture OsseoSpeed is based on:

- 1. Design similarities between the proposed Fixture OsseoSpeed and the currently marketed Fixtures within the Astra Tech Dental System.
- 2. Performance testing. The proposed and currently marketed devices are very similar in terms of size, materials of construction, performance characteristics, and basic design,

The differences have no effects on the performance or safety of the Fixture OsseoSpeed as evaluated in the performance testing. The same types of safety and effectiveness characteristics are raised with each of the devices. The changes described above do not raise new questions related to safety or efficacy of the implant.

In summary, the Fixture OsseoSpeed described in this submission is substantially equivalent to the predicate devices listed, which provide the same or similar functions, as well as design and technological characteristics. Similarly, the immediate loading claim for Fixture MicroMacro is based upon its substantial equivalence with other fixtures bearing this claim. The intended use, statement of indications, technological characteristics and testing for the Fixture OsseoSpeed and Fixture MicroMacro support the concept of substantial equivalence.

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### 7. Performance Testing

Laboratory testing was conducted to determine device functionality and conformance to design input requirements. The immediate loading claims for Fixture Osseospeed and Fixture MicroMacro were supported by clinical data.

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Public Health Service

JUN 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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: K024111

Trade/Device Name: Astra Tech Implants- Dental System Fixture OsseoSpeed Astra Tech Implants- Dental System Fixture MicroMarco Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: March 13, 2003 Received: March 14, 2003

Dear Mr. Manning:

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 application (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 such 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 -- Mr. Manning

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 (QS) 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 begin 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Gunner

Susan Runner, DDS, MA Interim 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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### Section 3

510(k) Number (if known): K024111

Device Name:

Astra Tech Implants - Dental System Fixture OsseoSpeed Astra Tech Implants - Dental System Fixture MicroMacro (new indication)

Indications For Use:

Fixture OsseoSpeed and Fixture MicroMacro are intended for endosseous implantation in the mandible and maxilla supporting single-tooth replacements. partial and total fixed detachable bridges and overdentures. One or two stage surgical procedure can be used. When using the one stage surgical protocol, immediate loading may be applied in the anterior mandibular region (between the mental foramina) if at least four implants are splinted with a bar, or other continuous suprastructure.

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

Kein Mely for nse

of Anesthesiology, General Hospital, n Control. Dental D

510(k) Number. K024111

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