The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobel Active 3.0.
| Device ID | K102436 |
| 510k Number | K102436 |
| Device Name: | NOBEL ACTIVE 3.0 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE AB 15 BOHUSGATAN, P.O. BOX 5190 Goteborg, SE S-402 26 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBEL BIOCARE AB 15 BOHUSGATAN, P.O. BOX 5190 Goteborg, SE S-402 26 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-26 |
| Decision Date | 2010-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747087567 | K102436 | 000 |
| 07332747037500 | K102436 | 000 |
| 07332747037494 | K102436 | 000 |
| 07332747037487 | K102436 | 000 |
| 07332747037470 | K102436 | 000 |
| 07332747037463 | K102436 | 000 |
| 07332747037456 | K102436 | 000 |
| 07332747037357 | K102436 | 000 |
| 07332747160635 | K102436 | 000 |
| 07332747160628 | K102436 | 000 |
| 07332747160611 | K102436 | 000 |
| 07332747037616 | K102436 | 000 |
| 07332747037623 | K102436 | 000 |
| 07332747037630 | K102436 | 000 |
| 07332747037739 | K102436 | 000 |
| 07332747037722 | K102436 | 000 |
| 07332747037715 | K102436 | 000 |
| 07332747037708 | K102436 | 000 |
| 07332747037692 | K102436 | 000 |
| 07332747037685 | K102436 | 000 |
| 07332747037678 | K102436 | 000 |
| 07332747037661 | K102436 | 000 |
| 07332747037654 | K102436 | 000 |
| 07332747037647 | K102436 | 000 |
| 07332747160604 | K102436 | 000 |