DW 277 #4

Alloy, Gold-based Noble Metal

IVOCLAR NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Dw 277 #4.

Pre-market Notification Details

Device IDK003633
510k NumberK003633
Device Name:DW 277 #4
ClassificationAlloy, Gold-based Noble Metal
Applicant IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactAndy Gulati
CorrespondentAndy Gulati
IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-24
Decision Date2000-12-20

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