ChlorCid, ChlorCid V, ChlorCid Surf

Cleanser, Root Canal

Ultradent Products, Inc.

The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Chlorcid, Chlorcid V, Chlorcid Surf.

Pre-market Notification Details

Device IDK173163
510k NumberK173163
Device Name:ChlorCid, ChlorCid V, ChlorCid Surf
ClassificationCleanser, Root Canal
Applicant Ultradent Products, Inc. 505 W Ultradent Drive (10200 South) South Jordan,  UT  84095
ContactCorey Jaseph
CorrespondentCorey Jaseph
Ultradent Products, Inc. 505 W Ultradent Drive (10200 South) South Jordan,  UT  84095
Product CodeKJJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2018-02-09
Summary:summary

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