The following data is part of a premarket notification filed by Midwest Orthodontic Mfg. with the FDA for Light-cure Pc.
Device ID | K952856 |
510k Number | K952856 |
Device Name: | LIGHT-CURE PC |
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 | 1995-09-12 |