Parkell Desensitizer Gel

Liner, Cavity, Calcium Hydroxide

Parkell, Inc.

The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Parkell Desensitizer Gel.

Pre-market Notification Details

Device IDK191103
501k NumberK191103
Device Name:Parkell Desensitizer Gel
ClassificationLiner, Cavity, Calcium Hydroxide
Applicant Parkell, Inc. 300 Executive Drive Edgewood,  NY  11717
ContactDavid Mott
CorrespondentDavid Mott
Parkell, Inc. 300 Executive Drive Edgewood,  NY  11717
Product CodeEJK  
CFR Regulation Number872.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-25
Decision Date2019-11-22

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