The following data is part of a premarket notification filed by Specialites Septodont with the FDA for Ionoscem Or Ionoscell Glass Ionomer Dental Cement.
| Device ID | K881661 |
| 510k Number | K881661 |
| Device Name: | IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT |
| Classification | Cement, Dental |
| Applicant | SPECIALITES SEPTODONT WASHINGTON SQUARE 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz SPECIALITES SEPTODONT WASHINGTON SQUARE 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-15 |
| Decision Date | 1988-06-07 |