The following data is part of a premarket notification filed by Aidite (qinhuangdao) Technology Co., Ltd. with the FDA for Aidite Pmma.
Device ID | K190217 |
510k Number | K190217 |
Device Name: | Aidite PMMA |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | Aidite (Qinhuangdao) Technology Co., Ltd. No.9 Dushan Road,Economic And Technological Development Zone Qinhuangdao, CN 066000 |
Contact | Zhang Wei |
Correspondent | Jessie You Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road , Nanshan District Shenzhen, CN Gd755 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-04 |
Decision Date | 2020-12-17 |