The following data is part of a premarket notification filed by Implant Innovations International, Inc. with the FDA for 3i Standard Threaded/self-tapping Threaded Implants Modification.
| Device ID | K935544 |
| 510k Number | K935544 |
| Device Name: | 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT INNOVATIONS INTERNATIONAL, INC. 3071 CONTINENTAL DR. West Palm Baeach, FL 33407 |
| Contact | William G Conety |
| Correspondent | William G Conety IMPLANT INNOVATIONS INTERNATIONAL, INC. 3071 CONTINENTAL DR. West Palm Baeach, 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 | 1993-11-12 |
| Decision Date | 1995-03-13 |