The following data is part of a premarket notification filed by Specialites Septodont with the FDA for Septopack Temporary Filling.
| Device ID | K915466 |
| 510k Number | K915466 |
| Device Name: | SEPTOPACK TEMPORARY FILLING |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
| Contact | Peter Reichertz |
| Correspondent | Peter Reichertz SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-05 |
| Decision Date | 1992-02-03 |