The following data is part of a premarket notification filed by Zhejiang Yinchili Medical Technology Co., Ltd. with the FDA for Custom-made Invisible Aligners.
| Device ID | K203624 |
| 510k Number | K203624 |
| Device Name: | Custom-made Invisible Aligners |
| Classification | Aligner, Sequential |
| Applicant | Zhejiang Yinchili Medical Technology Co., Ltd. North 4F, Building 1, No. 239 Yatai Road, Daqiao Town, Nanhu District Jiaxing, CN |
| Contact | Hangli Chen |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-11 |
| Decision Date | 2022-06-16 |