The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Lc Provifill.
| Device ID | K010012 |
| 510k Number | K010012 |
| Device Name: | LC PROVIFILL |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Contact | Jurgen Engelbrecht |
| Correspondent | Jurgen Engelbrecht S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-02 |
| Decision Date | 2001-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBIB735901 | K010012 | 000 |
| EBIB735801 | K010012 | 000 |
| EBIB735711 | K010012 | 000 |
| EBIB735701 | K010012 | 000 |
| EBIB735601 | K010012 | 000 |
| EBIB735411 | K010012 | 000 |
| EBIB735401 | K010012 | 000 |