The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelactive 8.5 Mm & 18.0 Mm.
| Device ID | K083205 |
| 510k Number | K083205 |
| Device Name: | NOBELACTIVE 8.5 MM & 18.0 MM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. 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 | 2008-10-30 |
| Decision Date | 2009-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747039849 | K083205 | 000 |
| 07332747160246 | K083205 | 000 |
| 07332747160253 | K083205 | 000 |
| 07332747160260 | K083205 | 000 |
| 07332747160277 | K083205 | 000 |
| 07332747160284 | K083205 | 000 |
| 07332747017922 | K083205 | 000 |
| 07332747017939 | K083205 | 000 |
| 07332747017946 | K083205 | 000 |
| 07332747017953 | K083205 | 000 |
| 07332747017960 | K083205 | 000 |
| 07332747017977 | K083205 | 000 |
| 07332747039719 | K083205 | 000 |
| 07332747039726 | K083205 | 000 |
| 07332747039771 | K083205 | 000 |
| 07332747039788 | K083205 | 000 |
| 07332747039832 | K083205 | 000 |
| 07332747160239 | K083205 | 000 |