The following data is part of a premarket notification filed by Specialites Septodont with the FDA for Septocal Cavity Liner.
| Device ID | K913574 |
| 510k Number | K913574 |
| Device Name: | SEPTOCAL CAVITY LINER |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-12 |
| Decision Date | 1991-09-30 |