The following data is part of a premarket notification filed by 3m Company with the FDA for Imprint Vinyl Polysiloxane Impression Material.
| Device ID | K882690 |
| 510k Number | K882690 |
| Device Name: | IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Contact | Don H Mckenzie |
| Correspondent | Don H Mckenzie 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-30 |
| Decision Date | 1988-08-11 |