BioMin Restore Plus

Varnish, Cavity

Dr. Collins, Inc.

The following data is part of a premarket notification filed by Dr. Collins, Inc. with the FDA for Biomin Restore Plus.

Pre-market Notification Details

Device IDK200077
510k NumberK200077
Device Name:BioMin Restore Plus
ClassificationVarnish, Cavity
Applicant Dr. Collins, Inc. 4330 Barranca Pkwy. Ste #100 Irvine,  CA  92604
ContactJiahe Li
CorrespondentJiahe Li
Dr. Collins, Inc. 4330 Barranca Pkwy. Ste #100 Irvine,  CA  92604
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-14
Decision Date2020-11-06

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