Cleared Traditional

K133040 - LED CURING LIGHT (FDA 510(k) Clearance)

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

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.

View all Monitex Industrial Co., Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 127d · This submission: 377d
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 212
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K133040.
Demi Pro
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LOOP™ LED Curing Light System (CLK01)
K241238 · Garrison Dental Solutions, LLC · Aug 2024
Curing Light, Model: MaxCure 9
K223414 · Guilin Refine Medical Instrument Co., Ltd. · Nov 2023