W-5

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 W-5.

Pre-market Notification Details

Device IDK022811
510k NumberK022811
Device Name:W-5
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 Received2002-08-23
Decision Date2002-10-09

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