BIOHORIZONS INTERNAL IMPLANT SYSTEM

K073268 · BioHorizons Implant Systems, Inc. · DZE · Feb 8, 2008 · Dental

Device Facts

• Record ID: K073268
• Device Name: BIOHORIZONS INTERNAL IMPLANT SYSTEM
• Applicant: BioHorizons Implant Systems, Inc.
• Product Code: DZE · Dental
• Decision Date: Feb 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BioHorizons Internal 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 Internal 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

Endosseous dental implant system; machined titanium alloy (ASTM F136) screw-form; used for tooth replacement/retention. Features Laser-Lok micro-machined grooves on collar to inhibit epithelial downgrowth and retain crestal bone. Surface treated with tricalcium phosphate or hydroxylapatite (ASTM F1185). Used by dental clinicians in clinical settings. Implant provides artificial root structure; supports immediate restoration under specific conditions (non-functional occlusion, splinting, or overdenture stabilization). Benefits include improved fixation and bone retention.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and technological similarities to predicate devices.

Technological Characteristics

Machined titanium alloy (ASTM F136); surface treated with tricalcium phosphate or hydroxylapatite (ASTM F1185). Laser-Lok micro-machined groove collar feature. Sterilized via radiation (ANSI/AAMI/ISO 11137-1). Screw-form geometry.

Indications for Use

Indicated for patients requiring single tooth replacement, fixed bridgework, or dental retention in the mandible or maxilla. Allows for immediate restoration with temporary prosthesis if not in functional occlusion, or when splinted for multiple tooth replacement, or stabilized with an overdenture 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 Internal Implant System (formerly The Prodigy System Dental Implants) (K042429)
• BioHorizons Tapered Internal Implant System (K071638)

Submission Summary (Full Text)

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n(k) Premarket Notification

BioHorizons Internal Implant System

Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically "K073268". The characters are bold and appear to be handwritten or stylized. The sequence consists of an uppercase letter 'K', followed by the number '0', then '73268'.

### 510(k) Summary 21 CFR 807.92

### ibmitter's Name & Address

| Manufacturer: | BioHorizons Implant Systems, Inc. |
|-------------------------------------|-------------------------------------------------------------|
| | 2300 Riverchase Center |
| | Birmingham, AL 35244 |
| | Phone [phone] |
| | Fax [phone] |
| Official contact:<br>Date prepared: | Winston Greer, Vice-President, QA & RA<br>November 19, 2007 |

rED -8 4000

#### ame of the Device

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

#### Predicate Devices

| BioHorizons Internal Implant System (formerly "The Prodigy System Dental · Implants"), documented under 510(k) number K042429, concurrence date of September 16, 2004.

2. BioHorizons Tapered Internal Implant System, documented under 510(k) number K071638, concurrence date of October 10, 2007.

### Device Description

BioHorizons Internal Implants are machined titanium, screw-form endosseous dental polants supplied in 3.5mm, 4.0mm, 6.0mm, 6.0mm diameters across lengths of 9mm. ( 5mm, 12mm and 15mm. Implant material is titanium alloy as specified in ASTM 196 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra ow Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

te devices are further processed by roughening the surface with tricalcium phosphate ast media, or by applying hydroxylapatite coating conforming to ASTM F1185 Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical miniants, to promote implant fixation. The product is packaged using materials known i the industry to be appropriate for medical device packaging and is provided with a ammum sterility assurance level of 10 €, validated in compliance to ANSI / AAMI / ISO 1137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for evelopment, validation and routine control of a sterilization process for medical evices.

the BioHorizons Internal Implant System includes a series of implant catalog item umbers with Laser-Lok® technology applied to the implant collar to provide additional reatment options for the dental implant clinician.

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# ntended Use

intended ประ
BioHorizons Internal Implants are intended for use in the maxilla as an a BioHorizons internal implants are intended for use in the fixed bridgework and dental retention.

BioHorizons Internal Implants may be restored immediately

- BioHonzons intornal insplants that is not in functional occlusion, or
- 1) when splinted together for multiple tooth replacement, or when stabilized with an
- when opture supported by multiple implants.

## Technological Characteristics

The fundamental scientific technology of the BioHorizons Internal Implant System of endosseous dental implant devices subject to this 510(k) is substantially or vivalent to the referenced predicate devices. The addition to the indications for use for conditional immediate restoration is substantially equivalent to the nredicate BioHorizons Tapered Internal Implant System (K071638), and immediate restoration is an accepted and prevalent clinical practice of demonstrated safety and efficacy. Laser-Lok is a surface feature in which patterns of micro-machined grooves are applied to the collar surface of a dental mplant 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 predicate BioHorizons Prodigy (K042429) and Tapered Internal endosseous mplants, and the Laser-Lok feature is substantially equivalent as that cleared for the Tapered Internal Implant System. The BioHorizons Internal Implant System which is the subject of this 510(k) is substantially equivalent to all features of the predicate BioHorizons Prodigy and Tapered Internal implant devices which could affect safety or effectiveness because of the similarities in design, materials and ntended 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 features a stylized eagle with three stripes representing the department's three main goals: health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB -8 2008

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

Re: K073268

Trade/Device Name: BioHorizons Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 19, 2007 Received: November 20, 2007

Dear Dr. 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 - Dr. 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 (OS) 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,

Chis Lisz, 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

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1 of 1

k) Number:

ice Name: BioHorizons Internal Implant System

ndications for Use:

gioHorizons Internal Implants are intended for use in the mandible or maxilla as an adficial root structure for single tooth replacement or for fixed bridgework and dental efention.

oHorizons Internal 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k073268

rescription Use per 21 CFR 801.109) OR

Over-the-Counter Use