Color Liquid, Vita Liquid

Powder, Porcelain

Zirkonzahn Srl

The following data is part of a premarket notification filed by Zirkonzahn Srl with the FDA for Color Liquid, Vita Liquid.

Pre-market Notification Details

Device IDK190518
501k NumberK190518
Device Name:Color Liquid, Vita Liquid
ClassificationPowder, Porcelain
Applicant Zirkonzahn Srl Via An Der Ahr 7 Gais,  IT 39030
ContactJulian Steger
CorrespondentSandra Leitner
Zirkonzahn Srl Via An Der Ahr 7 Gais,  IT 39030
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-04
Decision Date2019-11-22

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