Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Powder, Porcelain

Changsha Honchon Technology Co., LTD

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

Pre-market Notification Details

Device IDK221051
510k NumberK221051
Device Name:Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
ClassificationPowder, Porcelain
Applicant Changsha Honchon Technology Co., LTD Room 627-628, Building 3th, Jinqiao Market Cluster Area 2, Purui Road No.1555, Wangcheng Changsha,  CN 410200
ContactLing Li
CorrespondentShanfeng Jiang
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 Received2022-04-11
Decision Date2022-07-08

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