The following data is part of a premarket notification filed by Psp Dental Co., Ltd. with the FDA for Ceramchem, Ceramfil B, Straticem, Fluricem, Florio.
| Device ID | K853090 |
| 510k Number | K853090 |
| Device Name: | CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO |
| Classification | Cement, Dental |
| Applicant | PSP DENTAL CO., LTD. 3-5 DYLAN RD. Belvedere, Kent, GB Da17 5qs |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-23 |
| Decision Date | 1986-01-21 |