BruxZir Esthetic

Powder, Porcelain

Prismatik Dentalcraft, Inc.

The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Bruxzir Esthetic.

Pre-market Notification Details

Device IDK213425
510k NumberK213425
Device Name:BruxZir Esthetic
ClassificationPowder, Porcelain
Applicant Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine,  CA  96212
ContactSo Hyun Park
CorrespondentSo Hyun Park
Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine,  CA  96212
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-21
Decision Date2021-11-17

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