ENDOSSEOUS IMPLANT

K021355 · Branemark Integration AB · DZE · Aug 30, 2002 · Dental

Device Facts

• Record ID: K021355
• Device Name: ENDOSSEOUS IMPLANT
• Applicant: Branemark Integration AB
• Product Code: DZE · Dental
• Decision Date: Aug 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Brånemark Integration AB, FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

Device Story

The FIXTURE ORIGINAL is an endosseous dental implant designed for surgical placement into the upper or lower jaw bone. It serves as a permanent anchorage point for prosthetic devices, such as artificial teeth, to restore masticatory function. The device is a screw-type implant available in a 3.75 mm diameter with lengths ranging from 8.5 mm to 15 mm. It is intended for use by dental professionals in a clinical setting. The implant integrates with the jaw bone to provide a stable foundation for dental prosthetics, thereby benefiting patients by restoring their ability to chew.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and intended use similarities to the predicate device.

Technological Characteristics

Screw-type endosseous implant; diameter 3.75 mm; lengths 8.5-15 mm. Material composition is consistent with predicate dental implant standards. Designed for surgical implantation into jaw bone.

Indications for Use

Indicated for patients requiring permanent anchorage for prosthetic devices in the upper or lower jaw arches to restore chewing function.

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

• Nobel Biocare AB standard fixture RP (K925765)

Submission Summary (Full Text)

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K021355

## SECTION 2. SUMMARY AND CERTIFICATION

## A. 510(K) SUMMARY

## Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Brånemark Integration AB summary for the FIXTURE ORIGINAL.

| SUBMITTER'S NAME: | Brånemark Integration AB |
|---------------------|--------------------------------------------|
| ADDRESS: | Lilla Bommen 1, SE-411 04 Göteborg, Sweden |
| CONTACT PERSON: | Rickard Brånemark |
| TELEPHONE NUMBER: | [phone] |
| FAX NUMBER: | [phone] |
| DATE OF SUBMISSION: | April 22, 2002 |

#### 1. Identification of device

Proprietary Name: Endosseous Implant Common Name: FIXTURE ORIGINAL Classification Status: Class III per regulations 872.3640 Product Codes: DZE

#### 2. Equivalent devices

Brånemark Integration AB believes the FIXTURE ORIGINAL is substantially equivalent to Nobel Biocare AB standard fixture RP with a diameter of 3,75 mm.

#### 3. Description of the Device

The FIXTURE ORIGINAL consists of 4 implants, diameter 3,75 mm, and length from 8,5 to 15 mm.

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#### Intended use 4.

The Brånemark Integration AB, FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

#### Technological characteristics, comparison to predicate device. 5.

Like the predicate devices, the FIXTURE ORIGINAL is intended to restore masticator function.

| Characteristic | Nobel Biocare Standard Fixture | Brånemarsk Integration AB FIXTURE ORIGINAL |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | To be placed in the upper or lower<br>jaw to support prosthetic devices,<br>such as artificial teeth, and to restore<br>a patients chewing function. | The Brånemark Integration AB Fixture<br>Original is intended for surgical placement<br>into the bone of upper /lower jaw arches as a<br>permanent anchorage for prosthetic devices<br>and to restore chewing function. |
| Dimensions | Diameter 3,75 mm,<br>Length 7-20 mm | Diameter 3,75 mm<br>Length 8,5-15 mm |
| 510(k) | K925765 | No number yet |

### Comparison table

#### Discussion of performance testing. 6.

Mechanical testing requested for Screw-type Endosseous Implants are described in the Guideline "Information Necessary for Pre Market Notification Submission for Screw-Type Endosseous Implants", dated December 9, 1996.

Brånemark Integration AB, FIXTURE ORIGINAL is substantially equivalent to Nobel Biocare Standard Fixture in material, dimensions, and intended use why we have come to the conclusion that further testing will not raise new issues of safety and efficacy.

Please see section 5, Part B Performance Testing.

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#### Conclusion 7.

Based on comparison to the predicate device, the Brånemark Integration AB, FIXTURE ORIGINAL, is substantially equivalent to previously cleared Nobel Biocare AB and presents no new concerns about safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2002

Dr. Richard Branemark President Branemark Integration AB Lilla Bommen 1, 11 tr SE-411 04 Goteborg, SWEDEN

Re: K021355

Trade/Device Name: Fixture Original Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: August 5, 2002 Received: August 7, 2002

Dear Mr. Branemark:

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.

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.

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Page 2 - Dr. Branemark

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

Timothy A. Ulatowski 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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# 《021355

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## B. INDICATIONS FOR USE

510(k) Number

Device Name: Brånemark Integration AB, FIXTURE ORIGINAL.

Indications for Use:

The Brånemark Integration AB, FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

(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)

Suna Runa

esthesiology, General Hospital. Infection Control. De

510(k) Number: K051235