Clinpro Varnish

Varnish, Cavity

3m Company

The following data is part of a premarket notification filed by 3m Company with the FDA for Clinpro Varnish.

Pre-market Notification Details

Device IDK151302
510k NumberK151302
Device Name:Clinpro Varnish
ClassificationVarnish, Cavity
Applicant 3m Company 2510 Conway Avenue St. Paul,  MN  55144 -1000
ContactShari L. Myszka
CorrespondentShari L. Myszka
3m Company 2510 Conway Avenue St. Paul,  MN  55144 -1000
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-15
Decision Date2015-09-18
Summary:summary

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