EthanZir Zirconia

Powder, Porcelain

Besorah Dental Solutions NZ Limited

The following data is part of a premarket notification filed by Besorah Dental Solutions Nz Limited with the FDA for Ethanzir Zirconia.

Pre-market Notification Details

Device IDK191304
501k NumberK191304
Device Name:EthanZir Zirconia
ClassificationPowder, Porcelain
Applicant Besorah Dental Solutions NZ Limited 17/9 Chonny Crescent, Manurewa Auckland,  NZ 2102
ContactJobin Jose
CorrespondentRobin A. Carden
RAC Corporation 27134 Paseo Espada San Juan Capistrano,  CA  92675
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-14
Decision Date2019-11-04

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