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 |