Accusil Dental Impression Materials (Accusil Light Body Regular And Fast Set, Accusil Heavy Body Regular And Fast Set, Accusil Monophase Regular And Fast Set, Accusil Putty Regular And Fast Set, Accusil Bite Registration)

Material, Impression

Prevest Denpro Limited

The following data is part of a premarket notification filed by Prevest Denpro Limited with the FDA for Accusil Dental Impression Materials (accusil Light Body Regular And Fast Set, Accusil Heavy Body Regular And Fast Set, Accusil Monophase Regular And Fast Set, Accusil Putty Regular And Fast Set, Accusil Bite Registration).

Pre-market Notification Details

Device IDK213244
510k NumberK213244
Device Name:Accusil Dental Impression Materials (Accusil Light Body Regular And Fast Set, Accusil Heavy Body Regular And Fast Set, Accusil Monophase Regular And Fast Set, Accusil Putty Regular And Fast Set, Accusil Bite Registration)
ClassificationMaterial, Impression
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 -0172
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2022-09-09

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