The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Resin Cem.
| Device ID | K011431 |
| 510k Number | K011431 |
| Device Name: | RESIN CEM |
| Classification | Cement, Dental |
| Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Contact | Christian Bottcher |
| Correspondent | Christian Bottcher S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-09 |
| Decision Date | 2001-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850194007459 | K011431 | 000 |
| D745701198PVC00030 | K011431 | 000 |
| EBIB750601 | K011431 | 000 |
| 00850194007800 | K011431 | 000 |
| 00850194007817 | K011431 | 000 |
| 00850194007824 | K011431 | 000 |
| 00850194007831 | K011431 | 000 |
| 00850194007848 | K011431 | 000 |
| 00850194007855 | K011431 | 000 |
| 00850194007404 | K011431 | 000 |
| 00850194007411 | K011431 | 000 |
| 00850194007428 | K011431 | 000 |
| 00850194007435 | K011431 | 000 |
| 00850194007442 | K011431 | 000 |
| D745701198PVC00010 | K011431 | 000 |