Dental Glass Ceramics Blocks

Powder, Porcelain

Aidite (Qinhuangdao) Technology Co., Ltd.

The following data is part of a premarket notification filed by Aidite (qinhuangdao) Technology Co., Ltd. with the FDA for Dental Glass Ceramics Blocks.

Pre-market Notification Details

Device IDK192231
510k NumberK192231
Device Name:Dental Glass Ceramics Blocks
ClassificationPowder, Porcelain
Applicant Aidite (Qinhuangdao) Technology Co., Ltd. No.9 Dushan Road,Economic And Technological Development Zone Qinhuangdao,  CN 066000
ContactZhang Wei
CorrespondentChristy Young
Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road , Nanshan District Shenzhen,  CN Gd755
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-16
Decision Date2020-07-08

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