Cleared Traditional

LED Curing Lights (DB686 HALO)

K243921 · Foshan Coxo Medical Instrument Co., Ltd. · Dental
Apr 2025
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K243921 is an FDA 510(k) clearance for the LED Curing Lights (DB686 HALO), 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 April 11, 2025, 112 days after receiving the submission on December 20, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K243921 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2024
Decision Date April 11, 2025
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBZ — Activator, Ultraviolet, For Polymerization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6070

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