HELIOLINK TRY-IN PASTES

Material, Tooth Shade, Resin

IVOCLAR NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Heliolink Try-in Pastes.

Pre-market Notification Details

Device IDK903587
510k NumberK903587
Device Name:HELIOLINK TRY-IN PASTES
ClassificationMaterial, Tooth Shade, Resin
Applicant IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactGary Severance
CorrespondentGary Severance
IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-08
Decision Date1990-10-09

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