The following data is part of a premarket notification filed by Ortho Source with the FDA for Ortho Light Cure.
Device ID | K913854 |
510k Number | K913854 |
Device Name: | ORTHO LIGHT CURE |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood, CA 91607 |
Contact | Andrea G Mustachio |
Correspondent | Andrea G Mustachio ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood, CA 91607 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-27 |
Decision Date | 1992-01-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D9115578880 | K913854 | 000 |
D9115578810 | K913854 | 000 |
D9115578630 | K913854 | 000 |