SUPERLON (UNILON) CARBOXYLATE CEMENT

Cement, Dental

CARLISLE LABORATORIES, INC.

The following data is part of a premarket notification filed by Carlisle Laboratories, Inc. with the FDA for Superlon (unilon) Carboxylate Cement.

Pre-market Notification Details

Device IDK861685
510k NumberK861685
Device Name:SUPERLON (UNILON) CARBOXYLATE CEMENT
ClassificationCement, Dental
Applicant CARLISLE LABORATORIES, INC. 404 DOUGHTY BLVD. Inwood,  NY  11696
ContactMichael Stehn
CorrespondentMichael Stehn
CARLISLE LABORATORIES, INC. 404 DOUGHTY BLVD. Inwood,  NY  11696
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-02
Decision Date1986-05-19

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