BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM

K073282 · BioHorizons Implant Systems, Inc. · DZE · Feb 15, 2008 · Dental

Device Facts

• Record ID: K073282
• Device Name: BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM
• Applicant: BioHorizons Implant Systems, Inc.
• Product Code: DZE · Dental
• Decision Date: Feb 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BioHorizons Single-stage Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. BioHorizons Single-stage Implants may be restored immediately with a temporary prosthesis that is not in functional occlusion, or when splinted together for multiple tooth replacement, or when stabilized with an overdenture supported by multiple implants.

Device Story

BioHorizons Single-stage Implant System consists of machined titanium alloy (ASTM F136) screw-form endosseous dental implants. Available in diameters 3.5mm-6.0mm and lengths 9mm-15mm. Surface treated with tricalcium phosphate or hydroxylapatite (ASTM F1185) to promote fixation. Features Laser-Lok technology on the implant collar—a pattern of micro-grooves designed to inhibit epithelial cell downgrowth and retain crestal bone. Used by dental clinicians in clinical settings as artificial root structures for tooth replacement or dental retention. Implants are surgically placed in the mandible or maxilla. Immediate restoration is permitted under specific conditions: non-functional temporary prosthesis, splinting for multiple teeth, or stabilization with overdentures. Benefits include improved implant fixation and soft/hard tissue attachment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and technological similarities to legally marketed predicate devices. Bench testing includes sterilization validation per ANSI/AAMI/ISO 11137-1.

Technological Characteristics

Materials: Titanium-6Aluminum-4Vanadium ELI alloy (ASTM F136); Hydroxylapatite coating (ASTM F1185). Surface: Laser-Lok micro-grooved collar. Sterilization: Radiation (ANSI/AAMI/ISO 11137-1) with SAL 10^-6. Form factor: Screw-type endosseous implant. No software or electronic components.

Indications for Use

Indicated for patients requiring single tooth replacement, fixed bridgework, or dental retention in the mandible or maxilla. May be restored immediately with non-functional temporary prosthesis, splinted multiple tooth replacements, or overdentures supported by multiple 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

• BioHorizons Single-stage Implant System (K053152)
• BioHorizons Tapered Internal Implant System (K071638)

Submission Summary (Full Text)

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Premarket Notification

BioHorizons Single-stage Implant System

K073282

### 510(k) Summary 21 CFR 807.92

#### mitter's Name & Address

| Manufacturer: | BioHorizons Implant Systems, Inc. |
|-------------------|----------------------------------------|
| | 2300 Riverchase Center |
| | Birmingham, AL 35244 |
| | Phone [phone] |
| | Fax [phone] |
| Official contact: | Winston Greer, Vice-President, QA & RA |
| Date prepared: | November 20, 2007 |

#### ne of the Device

| Trade Name: | BioHorizons Single-stage Implant System |
|------------------------|-----------------------------------------|
| Common or Usual Name: | Screw-type dental implant |
| Classification Name: | Endosseous dental implant |
| Classification Number: | Class II (21 CFR 872.3640) |

#### icate Devices

- BioHorizons Single-stage Implant System, documented under 510(k) number 053152, concurrence date of December 2, 2005.
- BioHorizons Tapered Internal Implant System, documented under 510(k) number 071638, concurrence date of October 10, 2007.

#### ice Description

forizons Single-stage Implants are machined titanium, screw-form endosseous implants supplied in 3.5mm, 4.0mm, 5.0mm, 6.0mm diameters across lengths of 9mm, 10.5mm, 12mm and 15mm. Implant material is titanium alloy as specified "M F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI tra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

e devices are further processed by roughening the surface with tricalcium phosphate st media, or by applying hydroxylapatite coating conforming to ASTM F1185 ndard Specification for Composition of Ceramic Hydroxylapatite for Surgical ants, to promote implant fixation. The product is packaged using materials known fe industry to be appropriate for medical device packaging and is provided with a mum sterility assurance level of 108, validated in compliance to ANSI / AAMI / ISO 37-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for velopment, validation and routine control of a sterilization process for medical avices.

BioHorizons Single-stage Implant System includes a series of implant catalog item mbers with Laser-Lok® technology applied to the implant collar to provide additional atment options for the dental implant clinician.

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## Technological Characteristics

Technological Onaractoriouss
The fundamental scientific technology of the BioHorizons Single-stage Implant The lundamental occurities trendoss subject to this 510(k) is System of endooooooo dontal implant do noon of the addition to the substantially equivalorit to litional immediate restoration is substantially mailations for ass for octiations Tapered Internal Implant System equivalent to the proadiate restoration is an accepted and prevalent clinical (KV7 1000), und infribulate rest and efficacy. Laser-Lok is a surface feature in placitic of connectined grooves are applied to the collar surface of a which puttern to (1) inhibit epithelial cell downgrowth around the implant, and (2) attach and retain crestal bone adjacent to the implant. All materials, suppliers, processing, packaging and sterilization methods remain the same as for the oredicate BioHorizons Single-stage (K053152) and Tapered Internal endosseous mplants, and the Laser-Lok feature is substantially equivalent as that cleared for the Tapered Internal Implant System. The BioHorizons Single-stage Implant System which is the subject of this 510(k) is substantially equivalent to all features of the predicate BioHorizons Single-stage and Tapered Internal implant evices which could affect safety or effectiveness because of the similarities in sign, materials and intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.

Public Health Service

FEB 15 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Winston Greer Vice-President, Quality Assurance & Regulatory Affairs BioHorizons Implant Systems, Incorporated 2300 Riverchase Center Birmingham, Alabama 35244

Re: K073282

Trade/Device Name: BioHorizons Single-stage Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 20, 2007 Received: November 21, 2007

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. Greer

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/industry/support/index.html.

Sincerely yours,

Sayre y. Mckin Omd.

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

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of 1

Number:

ice Name: BioHorizons Single-stage Implant System

dications for Use:

BioHorizons Single-stage Implants are intended for use in the mandible or maxilla as an andficial root structure for single tooth replacement or for fixed bridgework and dental tefention.

ioHorizons Single-stage Implants may be restored immediately awith a temporary prosthesis that is not in functional occlusion, or when splinted together for multiple tooth replacement, or when stabilized with an overdenture supported by multiple implants.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

Division Sign-Off) ivision of Anesthesiology, General Hospital fection Control, Dental Devices

10(k) Number:

× 1.109)

OR

Over-the-Counter Use