Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

Liner, Cavity, Calcium Hydroxide

Prevest Denpro Limited

The following data is part of a premarket notification filed by Prevest Denpro Limited with the FDA for Prevest Denpro Cavity Liners (apacal Art, Cal Lc, Calcigel, Calultra).

Pre-market Notification Details

Device IDK212475
510k NumberK212475
Device Name:Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
ClassificationLiner, Cavity, Calcium Hydroxide
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 CodeEJK  
CFR Regulation Number872.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-06
Decision Date2022-05-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D96730001A04 K212475 000
D967300010 K212475 000

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