Lucitone Denture Base Materials

Resin, Denture, Relining, Repairing, Rebasing

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Lucitone Denture Base Materials.

Pre-market Notification Details

Device IDK182422
510k NumberK182422
Device Name:Lucitone Denture Base Materials
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant Dentsply Sirona 221 West Philadelphia Street, Suite 60 York,  PA  17404
ContactKarl Nittinger
CorrespondentKarl Nittinger
Dentsply Sirona 221 West Philadelphia Street, Suite 60 York,  PA  17404
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-06
Decision Date2018-12-18

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