The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for 3i Hydroxylapatite Coated Standard Threaded & Self-tapping Implants.
| Device ID | K955428 |
| 510k Number | K955428 |
| Device Name: | 3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT INNOVATIONS, INC. 3071 CONTINENTAL DR. West Palm Beach, FL 33407 |
| Contact | William G Conety |
| Correspondent | William G Conety IMPLANT INNOVATIONS, INC. 3071 CONTINENTAL DR. West Palm Beach, FL 33407 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-28 |
| Decision Date | 1996-02-08 |