The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Replace Tiunite Endosseous Implant.
| Device ID | K023113 |
| 510k Number | K023113 |
| Device Name: | REPLACE TIUNITE ENDOSSEOUS IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-19 |
| Decision Date | 2002-09-26 |
| Summary: | summary |