The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for S & C Vinyl Polysiloxane Impression Material.
| Device ID | K951075 |
| 510k Number | K951075 |
| Device Name: | S & C VINYL POLYSILOXANE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn, DE |
| Contact | Jurgen Englebrecht |
| Correspondent | Jurgen Englebrecht S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn, DE |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813277020288 | K951075 | 000 |
| 00813277020134 | K951075 | 000 |
| 00813277020141 | K951075 | 000 |
| 00813277020158 | K951075 | 000 |
| 00813277020165 | K951075 | 000 |
| 00813277020172 | K951075 | 000 |
| 00813277020189 | K951075 | 000 |
| 00813277020196 | K951075 | 000 |
| 00813277020226 | K951075 | 000 |
| 00813277020233 | K951075 | 000 |
| 00813277020240 | K951075 | 000 |
| 00813277020257 | K951075 | 000 |
| 00813277020264 | K951075 | 000 |
| 00813277020271 | K951075 | 000 |
| 00813277020127 | K951075 | 000 |