MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS

{0}------------------------------------------------ K04/1136 # 510(k) Summary ### SUBMITTER: #### Submitted on behalf of: | | Company Name: | Bio-Lok International Inc. | |--------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------| | | Address: | 368 South Military Trail<br>Deerfield Beach, FL 33442 | | | Telephone: | (954) 698-9998 | | | Fax: | (954) 698-9925 | | by: | Elaine Duncan, M.S.M.E., RAC<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082 | | | Telephone:<br>Fax: | 715-549-6035<br>715-549-5380 | | | CONTACT PERSON: | Elaine Duncan | | | DATE PREPARED: | April 27, 2004 | | | TRADE NAME: | Laser-Lok™ surface treatment for use with Silhouette™ &<br>Silhouette™ IC dental implant system | | | COMMON NAME: | Dental implant, Endosseous | | SUBSTANTIALLY EQUIVALENT TO: Laser-Lok surface treatment is a line extension (optional surface modification) to the Silhouette™ and Silhouette™ IC dental implants. These surface modified implants are substantially equivalent to the predicate the Silhouette™ and Silhouette™ IC dental implants previously cleared under 510(k) # 032454. Additionally, FDA has cleared similar surface treatments for dental implants, such as the surface treatment on the Astra Tech Fixture ST DESCRIPTION of the DEVICE: 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 to cither the Silhouette™ (hex-top) or Silhouette ™ IC (internal connection) dental implants. Soft tissue attachment to the Laser-Lok surface treatment and the alignment of its micro-grooves inhibits epithelial down-growth on Silhouette Implants. The LaserLok treated collar on the Silhouette Dental Implant has been shown to attach and retain bone adjacent to the implant 3,b a. Bone Response to Laser Microtextured Surfaces by Ricci, J.L., Charvet, J., Frenkel, S.R., Chang, R., Nadkarni, P., Turner, J., Alexander, H .: Chapter 25 in: Bone Engineering, ed; JE Davies, 2000, Em2 Inc., Toronto (pages 8 & 9). b. Advanced Surface Microtexturing Techniques to Enhance Bone and Soft Tissue Response to Dental Implants by Weiner, S., Simon, J., Ehrenberg, D.S., Zweig, B., Ricci, J.L.: presented at the Academy of Osseointegration 2003 Annual Meeting, Boston and pending publication in the International Journal of Oral and Maxillofacial Implants. {1}------------------------------------------------ #### 510(k) Summary-Continued KC4//R6 The Laser-Lok surface treatment on the collar does not reduce the safety and inflammation performance of Silhouette Implants. INDICATIONS FOR USE: The implant is designed for use in edentulous sites for support of complete INDICATIONS FOR USE. The mipant is designed 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 SUMMANY of TECTERS of TECH in a summary of all testing conducted to-date. Mechanical testing was done in accordance with the FDA guidance "Information for premarket notification Mcchanical (c.sting was done in accerdaims) ants" issued on December 9, 1996. Results from an submissions for screw-lype elidossedus implans "Issued on Decombor "1999 of the surface treatment to have sufficient mechanical static and dynamic strength. Additional test reports include finite element analysis, animal and clinical testing. {2}------------------------------------------------ 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its body and wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 2 2004 Bio-Lok International, Incorporated C/O Ms. Elaine Duncan President Paladin Medial, Incorporated P.O. Box 560 Stillwater, Minnesota 55082-0560 Re: K041136 Trade/Device Name: Laser-Lok Surface Treatment for Silhouette™ and Silhouette™ IC Endosseous Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: August 10, 2004 Received: August 11, 2004 Dear Ms. Duncan: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your was 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinons, or to activend Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin upprivation (the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 (1 Mr), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can or round in the lev announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 – Ms. Duncan Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA \$ Issualice of a substance on ples with other requirements mean that FDA has made a determination that your device complies with other popular mean that FDA has made a decemination that Journinistered by other Federal agencies. of the Act or any Federal statutes and regulations administered by perstreating of the Act of ally rederal statutes and registerents, including, but not limited to: registration You must comply with all the Act's requirements and manufacturing proctice You must comply with an the Act 3 requirement 801); good manufacturing practice and listing (21 CFR Part 807); labeling (21 CFR Part 801); group 800'; and i and listing (21 CFR Fart 807), labeling (21 CFR al results) // requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if requirements as set forth in the quality systems (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) This letter will anow you to begin maticoling your and equivalence of your device to a premarket notification. The FDA miding of basical on 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), a if you desire specific advice for your do roll and and and the regulation please contact the Office of Comphanes at (210) = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on Jour Land Consumer Assistance at its toll-free Division of Binastic or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Chiu Lin, 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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K041136 Device Name: Laser-Lok surface treatment for Silhouette™ and Silhouette™ IC endosseous implant Indications for Use: The implant is designed for use in edentulous sites for support of complete denture The implant is designed for use in coonarous of to fixed bridgework or partial dentures, prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentu prosulesis, a terminal or ment, overdenture, or hybrid denture. Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Pearson (Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | Koy 134<br>510(k) Number: _______________________________________________________________________________________________________________________________________________________________<br>And Advertising and the program and the first and the comments of the first and | Page 1 of<br>And and a minimal commend a province for the first to the first to the first to the first the first to the first and | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| .