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 |