Cleared Traditional

Coltolux Comfort LED Curing Light

K223142 · Dent4you AG · Dental
Dec 2022
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K223142 is an FDA 510(k) clearance for the Coltolux Comfort LED Curing Light, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Dent4you AG (Heerbrugg, CH). The FDA issued a Cleared decision on December 22, 2022, 79 days after receiving the submission on October 4, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K223142 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2022
Decision Date December 22, 2022
Days to Decision 79 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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