KULZER GLAS-IONOMER CEMENT

Cement, Dental

KULZER, INC.

The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Kulzer Glas-ionomer Cement.

Pre-market Notification Details

Device IDK892453
510k NumberK892453
Device Name:KULZER GLAS-IONOMER CEMENT
ClassificationCement, Dental
Applicant KULZER, INC. 111 N. WABASH AVE. Chicago,  IL  60602
ContactBauer, Phd
CorrespondentBauer, Phd
KULZER, INC. 111 N. WABASH AVE. Chicago,  IL  60602
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-10
Decision Date1989-12-04

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