The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Tiunite Implants.
| Device ID | K050705 |
| 510k Number | K050705 |
| Device Name: | TIUNITE IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-18 |
| Decision Date | 2005-05-19 |
| Summary: | summary |