The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Branemark System Zygomaticus Fixture System.
| Device ID | K970499 |
| 510k Number | K970499 |
| Device Name: | BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont, IL 60559 |
| Contact | Besty A Brown |
| Correspondent | Besty A Brown NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont, IL 60559 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747025231 | K970499 | 000 |
| 07332747159349 | K970499 | 000 |
| 07332747159356 | K970499 | 000 |
| 07332747159363 | K970499 | 000 |
| 07332747159332 | K970499 | 000 |
| 07332747159325 | K970499 | 000 |
| 07332747159295 | K970499 | 000 |
| 07332747159301 | K970499 | 000 |
| 07332747003871 | K970499 | 000 |
| 07332747025163 | K970499 | 000 |
| 07332747025170 | K970499 | 000 |
| 07332747025187 | K970499 | 000 |
| 07332747025194 | K970499 | 000 |
| 07332747025200 | K970499 | 000 |
| 07332747025217 | K970499 | 000 |
| 07332747025224 | K970499 | 000 |
| 07332747159318 | K970499 | 000 |