BIODENTINE
Resin, Root Canal Filling
SEPTODONT
The following data is part of a premarket notification filed by Septodont with the FDA for Biodentine.
Pre-market Notification Details
| Device ID | K092251 |
| 510k Number | K092251 |
| Device Name: | BIODENTINE |
| Classification | Resin, Root Canal Filling |
| Applicant | SEPTODONT 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Contact | Wayne Matelski |
| Correspondent | Wayne Matelski SEPTODONT 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-28 |
| Decision Date | 2009-10-30 |
Trademark Results [BIODENTINE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIODENTINE 98253720 not registered Live/Pending |
Henri Numa Marcel Schiller 2023-11-03 |
 BIODENTINE 77509635 3713946 Live/Registered |
Schiller, Henri Numa Marcel 2008-06-27 |
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