BIOUNIVERSAL PKF

Alloy, Gold-based Noble Metal

IVOCLAR VIVADENT, INC.

The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Biouniversal Pkf.

Pre-market Notification Details

Device IDK030435
510k NumberK030435
Device Name:BIOUNIVERSAL PKF
ClassificationAlloy, Gold-based Noble Metal
Applicant IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactAnderjeet Gulati
CorrespondentAnderjeet Gulati
IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-10
Decision Date2003-04-15

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