meddevicedb.com FDA Device Reference

Clear Aligners

K210373 Class II Traditional
Decision Date
2021-08-27
Sponsor / Applicant
Shenzhen Yinuo Dental Technology Co.Ltd

Technical Specification

510(k) Submission ID K210373
Product Code NXC
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.5470
Decision Date 2021-08-27
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Clear Aligners received FDA 510(k) clearance under submission number K210373, sponsored by Shenzhen Yinuo Dental Technology Co.Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-08-27.

Classification & Regulation

This clearance is catalogued under FDA product code NXC and 21 CFR 872.5470, within the Dental review panel as a Class II device.