CZ-S2000

Resin, Root Canal Filling

PARKELL, INC.

The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Cz-s2000.

Pre-market Notification Details

Device IDK060946
510k NumberK060946
Device Name:CZ-S2000
ClassificationResin, Root Canal Filling
Applicant PARKELL, INC. 300 EXECUTIVE DR. Edgewood,  NY  11717
ContactNelson J Gendusa
CorrespondentNelson J Gendusa
PARKELL, INC. 300 EXECUTIVE DR. Edgewood,  NY  11717
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-06
Decision Date2006-06-15
Summary:summary

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