MICRODOSE TOTAL ETCHANT

Material, Tooth Shade, Resin

UNICEP

The following data is part of a premarket notification filed by Unicep with the FDA for Microdose Total Etchant.

Pre-market Notification Details

Device IDK924826
510k NumberK924826
Device Name:MICRODOSE TOTAL ETCHANT
ClassificationMaterial, Tooth Shade, Resin
Applicant UNICEP P.O. BOX 1827 804 AIRPORT WAY Sandpoint,  ID  83864
ContactJohn Snedden
CorrespondentJohn Snedden
UNICEP P.O. BOX 1827 804 AIRPORT WAY Sandpoint,  ID  83864
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-28
Decision Date1993-03-05

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