BRIGHT GOLD

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 Bright Gold.

Pre-market Notification Details

Device IDK021892
510k NumberK021892
Device Name:BRIGHT GOLD
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 Received2002-06-07
Decision Date2002-07-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.