BruxZir Steel

Powder, Porcelain

Prismatik Dentalcraft, Inc.

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

Pre-market Notification Details

Device IDK200131
510k NumberK200131
Device Name:BruxZir Steel
ClassificationPowder, Porcelain
Applicant Prismatik Dentalcraft, Inc. 2212 Dupont Drive, Suite P Irvine,  CA  92612
ContactSo Hyun Park
CorrespondentSo Hyun Park
Prismatik Dentalcraft, Inc. 2212 Dupont Drive, Suite P Irvine,  CA  92612
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-21
Decision Date2020-06-10

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