Aidite PMMA

Crown And Bridge, Temporary, Resin

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 Aidite Pmma.

Pre-market Notification Details

Device IDK190217
510k NumberK190217
Device Name:Aidite PMMA
ClassificationCrown And Bridge, Temporary, Resin
Applicant Aidite (Qinhuangdao) Technology Co., Ltd. No.9 Dushan Road,Economic And Technological Development Zone Qinhuangdao,  CN 066000
ContactZhang Wei
CorrespondentJessie You
Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road , Nanshan District Shenzhen,  CN Gd755
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-04
Decision Date2020-12-17

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