Cleared Traditional

Coltolux Comfort LED Curing Light (K223142) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K223142 is an FDA 510(k) clearance for the Coltolux Comfort LED Curing Light. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dent4you AG (Heerbrugg, CH). The FDA issued a Cleared decision on December 22, 2022 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dent4you AG devices

Submission Details

510(k) Number K223142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBZ Activator, Ultraviolet, For Polymerization

All 42
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K223142.
Curing Light, Model: MaxCure 9
K223414 · Guilin Refine Medical Instrument Co., Ltd. · Nov 2023
BASE290 LED Curing Light
K233518 · Handpiece Headquarters · Nov 2023
CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
K223507 · Good Doctors Co., Ltd. · Aug 2023
LED Curing Light
K220826 · Foshan Coxo Medical Instrument Co., Ltd. · Dec 2022
CuringPen Dental Curing Light
K221152 · Changzhou Sifary Medical Technology Co., Ltd. · Nov 2022
LEDEX
K221194 · Dentmate Technology Co. , Ltd. · Sep 2022