ACTIVA PRESTO PACK

Material, Tooth Shade, Resin

Pulpdent Corporation

The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Activa Presto Pack.

Pre-market Notification Details

Device IDK210045
510k NumberK210045
Device Name:ACTIVA PRESTO PACK
ClassificationMaterial, Tooth Shade, Resin
Applicant Pulpdent Corporation 80 Oakland Street Watertown,  MA  02472
ContactLewis Berk
CorrespondentLewis Berk
Lewis Berk 80 Oakland Street Watertown,  MA  02472
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-08
Decision Date2021-09-22

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