The following data is part of a premarket notification filed by Shenzhen Yinuo Dental Technology Co.ltd with the FDA for Clear Aligners.
Device ID | K210373 |
510k Number | K210373 |
Device Name: | Clear Aligners |
Classification | Aligner, Sequential |
Applicant | Shenzhen Yinuo Dental Technology Co.LTD Xinfeng Industry Park No.11,101-301,Xintian Community, Guanhu Street, Longhua Shenzhen, CN 518000 |
Contact | Mo Yuyum |
Correspondent | Gamma Zhang Feiying Drug&Medical Consulting Technical Service Group Rm 218, Building 2, Yike Intelligent Innovation Park, No. 232 Kezhu Road, Huangpu, Guangzhou Guangzhou, CN 510000 |
Product Code | NXC |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-08 |
Decision Date | 2021-08-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06974803440001 | K210373 | 000 |