HARMONY LINE PF

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 Pf.

Pre-market Notification Details

Device IDK950517
510k NumberK950517
Device Name:HARMONY LINE PF
ClassificationAlloy, Gold-based Noble Metal
Applicant IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactLooyd V Ziemendorf
CorrespondentLooyd V Ziemendorf
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 Received1995-02-06
Decision Date1995-03-23

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