The following data is part of a premarket notification filed by Specialites Septodont with the FDA for Septosil Silicone For Precision Impression.
| Device ID | K851388 |
| 510k Number | K851388 |
| Device Name: | SEPTOSIL SILICONE FOR PRECISION IMPRESSION |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-09 |
| Decision Date | 1985-05-29 |