Cleared Traditional

LumiCera

K260170 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Dental

Jan 2026

Decision

Days

Class 2

Risk

About This 510(k) Submission

K260170 is an FDA 510(k) clearance for the LumiCera, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Hangzhou SHINING3D Dental Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 21, 2026, 1 days after receiving the submission on January 20, 2026. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K260170 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 20, 2026
Decision Date	January 21, 2026
Days to Decision	1 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF