The following data is part of a premarket notification filed by Scican with the FDA for Polysil (vinyl Polysiloxan Impression Material).
| Device ID | K945142 |
| 510k Number | K945142 |
| Device Name: | POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) |
| Classification | Material, Impression |
| Applicant | SCICAN 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Contact | Eva Young |
| Correspondent | Eva Young SCICAN 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-20 |
| Decision Date | 1995-01-11 |