The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Provi Cement.
| Device ID | K973201 |
| 510k Number | K973201 |
| Device Name: | PROVI CEMENT |
| Classification | Cement, Dental |
| Applicant | S & C POLYMER GMBH OFFENAUER WEG 19 D-25335 BOKHOLT-HARNREDDER Harnredder, DE |
| Contact | Jurgen Engelbrecht |
| Correspondent | Jurgen Engelbrecht S & C POLYMER GMBH OFFENAUER WEG 19 D-25335 BOKHOLT-HARNREDDER Harnredder, DE |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-26 |
| Decision Date | 1998-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBIB037201 | K973201 | 000 |
| EBIB037101 | K973201 | 000 |