MICRODOSE SILANE

Teeth, Porcelain

UNICEP

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

Pre-market Notification Details

Device IDK924823
510k NumberK924823
Device Name:MICRODOSE SILANE
ClassificationTeeth, Porcelain
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 CodeELL  
CFR Regulation Number872.3920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-28
Decision Date1993-03-16

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