The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for 3i Tg Osseotite Implant, Models Tg685, Tg610, Tg611, Tg613, Tg5685, Tg5610, Tg5611, Tg5613, Tg5615.
| Device ID | K033430 |
| 510k Number | K033430 |
| Device Name: | 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Tamara Nelson |
| Correspondent | Tamara Nelson IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-28 |
| Decision Date | 2003-11-07 |
| Summary: | summary |