The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Provisional Dental Implant System.
| Device ID | K984287 |
| 510k Number | K984287 |
| Device Name: | PROVISIONAL DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE UAS INC 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Contact | Jeff Hausheer |
| Correspondent | Jeff Hausheer NOBEL BIOCARE UAS INC 22895 EASTPARK DR. 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 | 1998-12-01 |
| Decision Date | 1999-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747016468 | K984287 | 000 |
| 17332747000693 | K984287 | 000 |