ORTHO LIGHT CURE

Adhesive, Bracket And Tooth Conditioner, Resin

ORTHO SOURCE

The following data is part of a premarket notification filed by Ortho Source with the FDA for Ortho Light Cure.

Pre-market Notification Details

Device IDK913854
510k NumberK913854
Device Name:ORTHO LIGHT CURE
ClassificationAdhesive, Bracket And Tooth Conditioner, Resin
Applicant ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood,  CA  91607
ContactAndrea G Mustachio
CorrespondentAndrea G Mustachio
ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood,  CA  91607
Product CodeDYH  
CFR Regulation Number872.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-27
Decision Date1992-01-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D9115578880 K913854 000
D9115578810 K913854 000
D9115578630 K913854 000

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