EPIEN ROOT CANAL CLEANSER

Cleanser, Root Canal

EPIEN MEDICAL, INC.

The following data is part of a premarket notification filed by Epien Medical, Inc. with the FDA for Epien Root Canal Cleanser.

Pre-market Notification Details

Device IDK123538
510k NumberK123538
Device Name:EPIEN ROOT CANAL CLEANSER
ClassificationCleanser, Root Canal
Applicant EPIEN MEDICAL, INC. 700 THIRTEENTH ST. NW STUITE 200 Washington,  DC  20005
ContactJeffrey K Shapiro
CorrespondentJeffrey K Shapiro
EPIEN MEDICAL, INC. 700 THIRTEENTH ST. NW STUITE 200 Washington,  DC  20005
Product CodeKJJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-16
Decision Date2013-02-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813110027337 K123538 000
00860004740308 K123538 000

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