SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)

K032454 · Bio-Lok Intl., Inc. · DZE · Mar 4, 2004 · Dental

Device Facts

• Record ID: K032454
• Device Name: SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)
• Applicant: Bio-Lok Intl., Inc.
• Product Code: DZE · Dental
• Decision Date: Mar 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The implant is designed for use in edentulous sites for support of complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.

Device Story

Silhouette™ and Silhouette™ IC are endosseous dental implants featuring self-tapping tapered designs; intended for surgical placement in edentulous sites by dental professionals. Implants incorporate Laser-Lok™ surface technology, consisting of laser-generated microscopic grooves on the collar to engineer biological width and tissue attachment. The screw thread portion utilizes Osseo-Lok™ surface roughening. The tapered design provides lateral compression of the osteotomy site and transfers forces to the bone while minimizing shear. These devices serve as anchors for various prosthetic restorations, including complete dentures, fixed bridges, and single tooth replacements, aiming to improve stability and tissue integration for the patient.

Clinical Evidence

Evidence includes mechanical testing (static and dynamic strength), finite element analysis, animal testing, and clinical testing. Testing conducted in accordance with FDA guidance for screw-type endosseous implants. Results indicate sufficient mechanical strength and biocompatibility.

Technological Characteristics

Self-tapping tapered endosseous dental implant; Laser-Lok™ laser-generated microscopic groove surface treatment on collar; Osseo-Lok™ surface roughening on threads. Mechanical design facilitates lateral compression of osteotomy site. No software or electronic components.

Indications for Use

Indicated for patients requiring dental restoration in edentulous sites, including support for complete dentures, fixed bridgework, partial dentures, single tooth replacement, overdentures, or hybrid dentures.

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

• Astra Tech Fixture ST
• Osseotite NT from 3i
• Prialit-2 by Dentsply Friadent Ceramed

Submission Summary (Full Text)

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MAR - 4 2004

K032454

## 510(k) Summary

## SUBMITTER:

Submitted on behalf of:

| | Company Name: | Bio-Lok International Inc. |
|-----------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | Address: | 312 South Military Trail<br>Deerfield Beach, FL 33442 |
| | Telephone: | [phone] |
| | Fax: | [phone] |
| by: | Elaine Duncan, M.S.M.E., RAC<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 | |
| Fax: | 715-549-5380 | |
| CONTACT PERSON: | Elaine Duncan | |
| DATE PREPARED: | August 7, 2003 | |
| TRADE NAME: | Silhouette™ & Silhouette™ IC dental implant system with<br>Laser-Lok™ surface treatment | |
| COMMON NAME: | Dental implant, Endosseous | |

SUBSTANTIALLY EQUIVALENT TO: Silhouette™ and Silhouette™ IC dental implants with SUBS I ANY IALD I BQ OT PREECT * * * * * * * * * * * * * * * implants [see manufacturer's various predicate 510(k)'s]. Additional substantially equivalent predicate devices with predicate vallous production 216(15) by break are the Astra Tech Fixture ST, Osseotite NT from 31, and Prialit-2 by Dentsply Friadent Ceramed.

DESCRIPTION of the DEVICE: The Silhouette™ (hex-top) and Silhouette ™ IC (internal connectivit) incorporate a self-tapping tapered implant design that provides lateral compression of the osteotomy site to meorporate a son-apping tapping aller and is flat in the lower supporting plane of the thread, passing compression forces to the bone and eliminating shear forces common to symmetrical the thead implants. The screw thead portion of the implants are surfaced roughened with Osseo-I ok™ per Bio-Coat, Inc. specifications. Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment.

INDICATIONS FOR USE: The implant is designed for use in edentulous sites for support of complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.

SUMMARY of TESTING: The Laser-Lok surface treatment does not introduce new issues for SUMMAN I of I DS I I W. The Base mary of all testing conducted to-date. Mechanical testing was blocompanibility as decambation for premation for premarket notification submissions for screwtype endosseous implants" issued on December 9, 1996. Results from an independent laboratory showed the Silhouette™ and Silhouette™ IC with Laser-Lok™ surface treatment to have sufficient mechanical slatic and dynamic strength. Additional test reports include finite element analysis, animal and clinical testing.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 2004

Biolock International, Ir.corporated Ms. Elaine Duncan President Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082-0560

Re: K032454

Nob2454
Trade/Device Name: Bio-Lok International, Incorporated Silhouette™ and Silhouette TM IC Endosseous Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE, NHA Dated: December 10, 2003 Received: December 11, 2003

Dear Ms. Duncan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your because mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, of to de rises and Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 000; Drag, and Commay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include confrols provisions of 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 If your device is classinod (obs acc iditional controls. Existing major regulations affecting (1 Wri), it may of backed of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be four of forther announcements concerning your device in the Federal Register.

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Page 2 - Ms. Falk

Please be advised that FIDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements Incall that I DT may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I outstal but is requirements, including, but not limited to: registration Tou must comply with as a mart 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 Or rel art 007), lacelity systems (QS) regulation (21 CFR Part 820); and if requirements as set fortis in the quadiation 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) I mis letter will and in Jour Jo The FDA finding of substantial equivalence of your device to a premarket notified.com - The Pice 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), If you desire specific at 110 to 100 login 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 may obtain 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,

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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510(k) Number (if known) __

Device Name: Bio-Lok International, Inc. Silhouette™ and Silhouette™ IC endosseous implant

K132454

Indications for Use:

The implant is designed for use in edentulous sites for support of complete denture I no implant is accrg. or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.

> (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_

(Optional Format 1-2-96)

Suse Rumm

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

510(k) Number: K032431