Cleared Traditional

K220826 - LED Curing Light
(FDA 510(k) Clearance)

K220826 · Foshan Coxo Medical Instrument Co., Ltd. · Dental

Dec 2022

Decision

261d

Days

Class 2

Risk

K220826 is an FDA 510(k) clearance for the LED Curing Light. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ).

Submitted by Foshan Coxo Medical Instrument Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on December 8, 2022, 261 days after receiving the submission on March 22, 2022.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number	K220826 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2022
Decision Date	December 08, 2022
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF