The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Replace Tps Coated Implants.
| Device ID | K002475 |
| 510k Number | K002475 |
| Device Name: | REPLACE TPS COATED IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE UAS INC 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Contact | Don Kennard |
| Correspondent | Don Kennard NOBEL BIOCARE UAS INC 22895 EASTPARK DR. 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 | 2000-08-11 |
| Decision Date | 2000-11-09 |