The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Vitremer Tri-cure Glass Ionomer System.
Device ID | K925032 |
510k Number | K925032 |
Device Name: | 3M VITREMER TRI-CURE GLASS IONOMER SYSTEM |
Classification | Cement, Dental |
Applicant | 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
Contact | Scott T Erickson |
Correspondent | Scott T Erickson 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-05 |
Decision Date | 1992-12-23 |