The following data is part of a premarket notification filed by Psp Dental Co., Ltd. with the FDA for Emperor 5/20 & Std, C.c, Ortho, Psp Refit, Perisea.
| Device ID | K853094 |
| 510k Number | K853094 |
| Device Name: | EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | PSP DENTAL CO., LTD. 3-5 DYLAN RD. Belvedere, Kent, GB Da17 5qs |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-23 |
| Decision Date | 1986-04-04 |