BruxZir GT (Gum Tissue) Color

Powder, Porcelain

Prismatik Dentalcraft, Inc.

The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Bruxzir Gt (gum Tissue) Color.

Pre-market Notification Details

Device IDK191903
501k NumberK191903
Device Name:BruxZir GT (Gum Tissue) Color
ClassificationPowder, Porcelain
Applicant Prismatik Dentalcraft, Inc. 2212 Dupont Dr. Irvine,  CA  92612
ContactMythili Reguraman
CorrespondentMythili Reguraman
Prismatik Dentalcraft, Inc. 2212 Dupont Dr. Irvine,  CA  92612
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-16
Decision Date2019-11-22

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