Dental Zirconia Ceramic

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 Zirconia Ceramic.

Pre-market Notification Details

Device IDK213570
510k NumberK213570
Device Name:Dental Zirconia Ceramic
ClassificationPowder, Porcelain
Applicant Aidite (Qinhuangdao) Technology Co., Ltd. No.9 Dushan Road,Economic And Technological Development Zone, Qinhuangdao,  CN 066004
ContactWang Lili
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lu Jiazui Rd.,Pudong Shanghai,  CN 200120
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-10
Decision Date2022-01-07

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