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 |