Cleared Traditional

K133040 - LED CURING LIGHT

K133040 is an FDA 510(k) clearance for LED CURING LIGHT, manufactured by Monitex Industrial Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K133040 · Monitex Industrial Co., Ltd. · Dental device
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Oct 2014
Decision
377d
Days
Class 2
Risk

K133040 is an FDA 510(k) clearance for the LED CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Monitex Industrial Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on October 7, 2014 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K133040

510(k) Number K133040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2013
Decision Date October 07, 2014
Days to Decision 377 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 128d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

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 195
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K133040.
Sirius Max Dental Diode Curing Light
K152936 · National Dental, Inc. · Nov 2015
LED Curing Light
K150205 · Monitex Industrial Co., Ltd. · Aug 2015
HI-LIGHT, HI-LIGHT PLUS
K140432 · Dentall Corporation · Aug 2015
FLEXI-LUME LED SYSTEM
K140281 · Epic Medical Concepts & Innovations · Jul 2014
SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE
K131906 · Satelec - Acteon Group · Apr 2014
LEDEX
K131042 · Dentmate Technology Co. , Ltd. · Oct 2013