Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Powder, Porcelain

Zirdent New Material Co., Ltd

The following data is part of a premarket notification filed by Zirdent New Material Co., Ltd with the FDA for Zirdent Dental Zirconia Blank & Dental Zirconia Pre-shaded Blank.

Pre-market Notification Details

Device IDK212259
510k NumberK212259
Device Name:Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
ClassificationPowder, Porcelain
Applicant Zirdent New Material Co., Ltd No.101,3rd Building Of Hai Ping International Medical Device Industrial Area, No.229, Guyuan Road, Hi-tech New District Changsha,  CN 410205
ContactJia Li
CorrespondentJinghua Zhou
Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City,  CN 510663
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-20
Decision Date2021-11-12

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