The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Tempcare Light Cure Temporary System.
Device ID | K944981 |
510k Number | K944981 |
Device Name: | 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | 3M COMPANY 2111 MCGAW AVE. Irvine, CA 92714 |
Contact | Amy E Fowler |
Correspondent | Amy E Fowler 3M COMPANY 2111 MCGAW AVE. Irvine, CA 92714 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-07 |
Decision Date | 1994-12-02 |