The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for Osseotite; Osseotite Nt; Xp; Tg Osseotite.
| Device ID | K063286 |
| 510k Number | K063286 |
| Device Name: | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Jacquelyn A Hughes |
| Correspondent | Jacquelyn A Hughes IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-31 |
| Decision Date | 2007-04-24 |
| Summary: | summary |