Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)

Cement, Dental

Prevest Denpro Limited

The following data is part of a premarket notification filed by Prevest Denpro Limited with the FDA for Prevest Denpro Dental Cements (micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner).

Pre-market Notification Details

Device IDK200555
510k NumberK200555
Device Name:Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)
ClassificationCement, Dental
Applicant Prevest Denpro Limited Export Promotion Industrial Park Bari Brahmana,  IN 181133
ContactAtul Modi
CorrespondentAngela Blackwell
Blackwell Device Consulting P.O. BOX 718 Gresham,  OR  97030
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-03
Decision Date2021-05-13

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