The following data is part of a premarket notification filed by Midwest Orthodontic Mfg. with the FDA for Light-cure.
| Device ID | K952858 |
| 510k Number | K952858 |
| Device Name: | LIGHT-CURE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | MIDWEST ORTHODONTIC MFG. 4570 PROGRESS DR. Columbus, IN 47201 |
| Contact | Jeffrey L Fasnacht |
| Correspondent | Jeffrey L Fasnacht MIDWEST ORTHODONTIC MFG. 4570 PROGRESS DR. Columbus, IN 47201 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-22 |
| Decision Date | 1995-09-05 |