The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Procera Titanium Abutment For Astratech And Camlog Implant Systems.
| Device ID | K061478 |
| 510k Number | K061478 |
| Device Name: | PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Phuong Nguyen Son |
| Correspondent | Phuong Nguyen Son NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-30 |
| Decision Date | 2006-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747100334 | K061478 | 000 |
| 07332747000320 | K061478 | 000 |
| 07332747012019 | K061478 | 000 |
| 07332747012422 | K061478 | 000 |
| 07332747013832 | K061478 | 000 |
| 07332747013849 | K061478 | 000 |
| 07332747100297 | K061478 | 000 |
| 07332747100303 | K061478 | 000 |
| 07332747100310 | K061478 | 000 |
| 07332747100327 | K061478 | 000 |
| 07332747000313 | K061478 | 000 |