HARMONY LINE ALLOYS

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 Harmony Line Alloys.

Pre-market Notification Details

Device IDK905330
510k NumberK905330
Device Name:HARMONY LINE ALLOYS
ClassificationAlloy, Gold-based Noble Metal
Applicant IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactGary L Severance
CorrespondentGary L Severance
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 Received1990-11-28
Decision Date1990-12-24

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