The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Multi-unit Abutments For Astratech, Camlog And Ankylos Implant Systems.
| Device ID | K061477 |
| 510k Number | K061477 |
| Device Name: | MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS 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 | 2006-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747003543 | K061477 | 000 |
| 07332747003536 | K061477 | 000 |
| 07332747003413 | K061477 | 000 |
| 07332747000665 | K061477 | 000 |
| 07332747000658 | K061477 | 000 |
| 07332747000641 | K061477 | 000 |
| 07332747000634 | K061477 | 000 |
| 07332747000627 | K061477 | 000 |