The following data is part of a premarket notification filed by 3m Company with the FDA for Vinyl Polysiloxane Impression Material.
| Device ID | K800485 |
| 510k Number | K800485 |
| Device Name: | VINYL POLYSILOXANE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | 3M COMPANY 8124 PACIFIC AVE. White City, OR 97503 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-04 |
| Decision Date | 1980-03-18 |