BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM

K071638 · BioHorizons Implant Systems, Inc. · DZE · Oct 10, 2007 · Dental

Device Facts

• Record ID: K071638
• Device Name: BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
• Applicant: BioHorizons Implant Systems, Inc.
• Product Code: DZE · Dental
• Decision Date: Oct 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The BioHorizons Tapered Internal Implant System is intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The BioHorizons Tapered Internal Implant System may be restored immediately 1 ) with a temporary prosthesis that is not in functional occlusion or 2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

Device Story

System of tapered, threaded, internal connection, root form dental implants and matching abutments; used as artificial root structure for tooth replacement or dental retention. External design incorporates Laser-Lok collar; internal connection and platform design derived from BioHorizons Prodigy System. Used by dental professionals in clinical settings for surgical implantation into mandible or maxilla. Provides foundation for prosthetic restoration; supports immediate loading under specific conditions (non-functional temporary prosthesis or splinted/stabilized configurations). Benefits include restoration of dental function and aesthetics.

Clinical Evidence

No clinical data.

Technological Characteristics

Tapered, threaded, internal connection, root form dental implants. Features Laser-Lok collar. Materials and specifications not detailed beyond design lineage to Bio-Lok and Prodigy systems. Class II medical device.

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 non-functional temporary prosthesis or when splinted/stabilized for multiple tooth replacement or overdentures.

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.

Reference Devices

• Bio-Lok Implant System
• BioHorizons Prodigy System

Submission Summary (Full Text)

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## 510(k) Summary

# K071638

## BioHorizons Implant Systems, Inc. BioHorizons Tapered Internal Implant System

007 10 2007

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | BioHorizons Implant Systems, Inc.<br>One Perimeter Park South, Suite 230 South<br>Birmingham, AL 35243 USA<br>Telephone [phone]<br>Fax [phone] |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Official Contact:

Winston Greer

Representative/Consultant:

Linda Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone [phone] : Fax [phone] email: [e-mail] [e-mail]

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | BioHorizons Tapered Internal Implant System |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Dental implants and abutments |
| Classification Regulations: | Endosseous dental implant<br>(21 CFR 872.3640), Class II<br>Endosseous dental implant abutment<br>(21 CFR 872.3630), Class II |
| Product Codes | DZE, NHA |

DEVICE CLASSIFICATION PANEL

The Classification Panel for these devices is the Dental Products Panel, and they are reviewed by the Dental Devices Branch.

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#### INTENDED USE

The BioHorizons Tapered Internal Implant System is intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention.

The BioHorizons Tapered Internal Implant System may be restored immediately

l ) with a temporary prosthesis that is not in functional occlusion or

2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

#### DEVICE DESCRIPTION

BioHorizons Tapered Internal Implant System is a system of tapered, threaded, internal connection, root form implants and matching abutments intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The external design of the implant is the same as that of the Bio-Lok Implant System, including the Laser-Lok® collar. The internal connection and the platform are the same as those of the BioHorizons Prodigy System™ Endosseous Implants.

#### EQUIVALENCE TO MARKETED PRODUCT

BioHorizons Implants Systems, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the BioHorizons Tapered Internal Implant System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices,

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized graphic. The graphic consists of three abstract shapes that resemble human figures or flowing lines, stacked on top of each other.

OCT 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BioHorizons Implant Systems, Incorporated C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 EL Camino Real, Suite 200 San Diego, California 92130

Re: K071638

Trade/Device Name: BioHorizons Tapered Internal Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 26, 2007 Received: September 27, 2007

Dear Ms. Schulz:

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 - Ms. Schulz

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,

Syitte y. Michael 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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### Indications for Use

510(k) Number (if known): KD 71633

Device Name:

BioHorizons Tapered Internal Implant System

Indications for Use:

The BioHorizons Tapered Internal Implant System is intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention.

The BioHorizons Tapered Internal Implant System may be restored immediately

- 1) with a temporary prosthesis that is not in functional occlusion or
- 2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> |
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| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |

| 510(k) Number: | K071638 |
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