The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Branemark Novum.
| Device ID | K000018 |
| 510k Number | K000018 |
| Device Name: | BRANEMARK NOVUM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE UAS INC 22725 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Kathleen Dragovich |
| Correspondent | Kathleen Dragovich NOBEL BIOCARE UAS INC 22725 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 | 2000-01-04 |
| Decision Date | 2000-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747024760 | K000018 | 000 |
| 17332747000990 | K000018 | 000 |
| 17332747000938 | K000018 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BRANEMARK NOVUM 75727945 not registered Dead/Abandoned |
Branemark Osseointegration AG 1999-06-14 |