ARISTON PHC LINER

Cement, Dental

IVOCLAR NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Ariston Phc Liner.

Pre-market Notification Details

Device IDK981335
510k NumberK981335
Device Name:ARISTON PHC LINER
ClassificationCement, Dental
Applicant IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactPeter P Mancuso
CorrespondentPeter P Mancuso
IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-13
Decision Date1998-07-02

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