510(k) clearance

Shining3D Clear Aligner System

FDA 510(k) source

510(k) number

K263860

Applicant

Hangzhou SHINING3D Dental Technology Co., Ltd.

Decision date

Oct 30, 2026

Date received

Oct 29, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NXC

Device type

Aligner, Sequential

Device class

Class II

Regulation

21 CFR 872.5470

Advisory committee

Dental

Statement or summary

Summary

Third party

Y

Location

Hangzhou, CN