BIOHORIZONS SINGLE-STAGE IMPLANT

K053152 · BioHorizons Implant Systems, Inc. · DZE · Dec 2, 2005 · Dental

Device Facts

• Record ID: K053152
• Device Name: BIOHORIZONS SINGLE-STAGE IMPLANT
• Applicant: BioHorizons Implant Systems, Inc.
• Product Code: DZE · Dental
• Decision Date: Dec 2, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of BioHorizons Single-stage endosseous implants is in the mandible and maxilla as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

Device Story

BioHorizons Single-stage implants are screw-form dental implants; used as artificial root structures for tooth replacement or prosthetic abutments. Implants are surgically placed in mandible or maxilla by dental professionals. Device provides stable foundation for fixed bridgework or denture retention. Benefits include restoration of dental function and aesthetics.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Machined titanium alloy (ASTM F 136, UNS R56401). Surface treated with tricalcium phosphate blast media or hydroxylapatite coating (ASTM F 1185). Diameters: 3.5mm, 4mm, 5mm, 6mm; Lengths: 7mm-15mm. Sterilization: Radiation (ANSI/AAMI/ISO 11137).

Indications for Use

Indicated for patients requiring single tooth replacement or abutments for fixed bridgework and denture retention in the mandible or maxilla.

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

• Maestro System extended collar implants (K020645)
• Prodigy System internal-connection implants (K042429)

Submission Summary (Full Text)

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BioHorizons Implant Systems, Inc. BioHorizons Single-stage Implants Special 510(k) Notification November 8, 2005 DEC 2

K053/52

2005

# 510(k) Summary 21 CFR 807.92

## Submitter's Name & Address

| Manufacturer: | BioHorizons Implant Systems, Inc.<br>One Perimeter Park South<br>Suite 230 South<br>Birmingham, AL 35243<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official contact:<br>Date prepared: | Winston Greer, Vice-President, QA & RA<br>October 25, 2005 |

## Name of the Device

| Trade Name: | BioHorizons Single-stage Implant |
|------------------------|-------------------------------------------------------------------------|
| Common or Usual Name: | Screw-type Dental Implant |
| Classification Name: | Endosseous implants, surgical components, and prosthetic<br>attachments |
| Classification Number: | Class II |

## Predicate Devices

- 1. The Maestro System extended collar implants, documented under 510(k) number K020645, concurrence date of March 15, 2002.
- 2. The Prodigy System internal-connection implants, documented under 510(k) number K042429, concurrence date of September 16, 2005.

# Device Description

The BioHorizons Single-stage dental implants are machined titanium, screw-form implants supplied in 3.5mm, 4mm, 5mm, 6mm diameters across lengths of 7mm, 9mm, 10.5mm 12mm and 15mm. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The devices are further processed by roughening the surface with tricalcium phosphate blast media, or by applying hydroxylapatite coating conforming to ASTM Fi 185, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants, to promote implant fixation. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a 11/10T - n sterility assurance level of 10 °, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.

#### Intended Use

The intended use of BioHorizons Single-stage endosseous implants is in the mandible and maxilla as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

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#### BioHorizons Implant Systems, Inc. BioHorizons Single-stage Implants Special 510(k) Notification November 8, 2005

K053/52

## Technological Characteristics

The fundamental scientific technology of the device is identical to the referenced predicate devices. All materials, suppliers, processing, packaging and sterilization methods remain the same as for the predicate BioHorizons Single-stage endosseous implants. The BioHorizons Single-stage implants are substantially equivalent to all features of the predicate Maestro System and Prodigy System device which could affect safety or effectiveness because of the similarities in design, material and intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three wavy lines extending from its body.

Public Health Service

DEC 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Winston Greer Vice President, Quality Assurance & Regulatory Affairs Biohorizons Implants Systems, Incorporated One Perimeter Park South Suite 230, South Birmingham, Alabama 35243

Re: K053152

Trade/Device Name: BioHorizons Single-Stage Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: November 8, 2005 Received: November 10, 2005

Dear Mr. Greer:

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. Lichtenwalner

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 and instille (s 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/industry/support/index.html.

Sincerely vours,

Chiu-Ling, 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

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510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: BioHorizons Single-stage Implant

Indications for Use:

The BioHorizons Single-stage implant may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:left;">✓</div> | OR | Over-the-Counter Use |
|----------------------|---------------------------------------|----|----------------------|
| (per 21 CFR 801.109) | | | |


| Sign-Off |
|-----------------------------------------------|
| Division of Anesthesiology, General Hospital, |
| Section Control, Dental Devices |

| Member Number: | K053152 |
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