BioHorizons Implant Systems, Inc. Warning Letter Department of Health and Human Services Public Health Service Food and Drug Administration New Orleans District Southeast Region 6600 Plaza Drive, Suite 400 New Orleans, LA 70127 Telephone: 504-253-4519 FAX: 504-253-4520 December 27, 2004 WARNING LETTER NO. 2005-NOL-08 FEDERAL EXPRESS OVERNIGHT DELIVERY Mr. R. Steven Boggan, President and CEO BioHorizons Implant Systems, Inc. One Perimeter Park South Suite 230, South Bir ...

Biomedical Implant Technology, Inc. Warning Letter Department of Health and Human Services Food and Drug Administration 2098 Gaither Road Rockville MD 20850 CERTIFIED MAIL RETURN RECEIPT REQUESTED Dr. Norman H. Kwan President and CEO Biomedical Implant Technology, Inc. 188 Bunting Road, Unit 8 St. Catharines, Ontario, CANADA Dear. Dr. Kwan: During an inspection of your facility located in St. Catharines, Ontario, Canada, on June 3- 5, 2002, our investigator determined that your fir ...

September 4, 1997 Fredrick N. Hanosh, President Implant Integration Systems, LLC 10490 San Felipe Rd. Cupertino, CA 95104 Dear Mr. Hanosh: We are writing to you because between July 14 and July21, 1997, Patricia A. Cruz, an investigator from the San Francisco District of the Food and Drug Administration (FDA), conducted an inspection of your firm and determined that you manufacture dental implant accessories known as “Parallel Pins “, “Depth Gauge”, and “Surgical Ratchet”. These products a ...

May 2, 1997 19900 MacArthur Blvd., Ste 300 Irvine, California 92715-2445 Telephone (71 4) 798-7600 WL-22-7 Kenneth A. Darienzo Chief Executive Officer Steri-Oss Inc. 22895 Eastpark Drive Yorba Linda, CA 92887 Dear Mr. Darienzo: During an inspection of your manufacturing facility conducted between April 7, and April 18, 1997, our investigator determined that your firm manufactures dental implant abutments and dental instruments. These products are devices as defined by Section 201(h) o ...