The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for S & C Hydro Vinyl Polysiloxane Impression Material.
| Device ID | K012767 |
| 510k Number | K012767 |
| Device Name: | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STRABE 5 Elmshorn, DE D-25335 |
| Contact | Christian Bottcher |
| Correspondent | Christian Bottcher S & C POLYMER GMBH ROBERT-BOSCH-STRABE 5 Elmshorn, DE D-25335 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-17 |
| Decision Date | 2001-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHAR70837521 | K012767 | 000 |
| EHAR70837021 | K012767 | 000 |
| EHAR70837011 | K012767 | 000 |
| D6620708547782 | K012767 | 000 |
| D6620708547602 | K012767 | 000 |
| D6620710313762 | K012767 | 000 |
| 00359883006389 | K012767 | 000 |
| 00359883004521 | K012767 | 000 |
| 00359883004507 | K012767 | 000 |
| EHAR70837111 | K012767 | 000 |
| EHAR70837121 | K012767 | 000 |
| EHAR70837211 | K012767 | 000 |
| EHAR70837511 | K012767 | 000 |
| EHAR70837421 | K012767 | 000 |
| EHAR70837411 | K012767 | 000 |
| EHAR70837401 | K012767 | 000 |
| EHAR70837331 | K012767 | 000 |
| EHAR70837321 | K012767 | 000 |
| EHAR70837311 | K012767 | 000 |
| EHAR70837221 | K012767 | 000 |
| 00359883004477 | K012767 | 000 |