Purzir Dental Zirconia

Powder, Porcelain

3DBioCAD

The following data is part of a premarket notification filed by 3dbiocad with the FDA for Purzir Dental Zirconia.

Pre-market Notification Details

Device IDK193055
510k NumberK193055
Device Name:Purzir Dental Zirconia
ClassificationPowder, Porcelain
Applicant 3DBioCAD 1525 N 4th St. Renton,  WA  98057
ContactGyu D. Cho
CorrespondentStuart R. Goldman
EMERGO Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin,  TX  78746
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-01
Decision Date2020-05-13

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