The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Branemark System(r) Ebon(tm) Fixture.
| Device ID | K974828 |
| 510k Number | K974828 |
| Device Name: | BRANEMARK SYSTEM(R) EBON(TM) FIXTURE |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont, IL 60559 |
| Contact | Betsy A Brown |
| Correspondent | Betsy 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 | 1997-12-24 |
| Decision Date | 1998-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747013344 | K974828 | 000 |
| 07332747013238 | K974828 | 000 |
| 07332747013245 | K974828 | 000 |
| 07332747013252 | K974828 | 000 |
| 07332747013269 | K974828 | 000 |
| 07332747013276 | K974828 | 000 |
| 07332747013283 | K974828 | 000 |
| 07332747013290 | K974828 | 000 |
| 07332747013306 | K974828 | 000 |
| 07332747013313 | K974828 | 000 |
| 07332747013320 | K974828 | 000 |
| 07332747013337 | K974828 | 000 |
| 07332747013221 | K974828 | 000 |