MAXUM DENTURE RESIN

Resin, Denture, Relining, Repairing, Rebasing

DENTSPLY INTL.

The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Maxum Denture Resin.

Pre-market Notification Details

Device IDK800400
510k NumberK800400
Device Name:MAXUM DENTURE RESIN
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant DENTSPLY INTL. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-02-26
Decision Date1980-03-12

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