Cleared Traditional

K161855 - LED Curing Light (FDA 510(k) Clearance)

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

K161855 · Monitex Industrial Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
509d
Days
Class 2
Risk

K161855 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 November 27, 2017 after a review of 509 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Monitex Industrial Co., Ltd. devices

Submission Details

510(k) Number K161855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2016
Decision Date November 27, 2017
Days to Decision 509 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
382d slower than avg
Panel avg: 127d · This submission: 509d
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 K161855.
Demi Pro
K253461 · Meta Systems Co., Ltd. · Oct 2025
Bluemoon
K242386 · Genoss Co., Ltd. · May 2025
LED Curing Lights (DB686 HALO)
K243921 · Foshan Coxo Medical Instrument Co., Ltd. · Apr 2025
LED Curing Light (C01-X, C02-X)
K250009 · Premium Plus (Dongguan) Limited · Apr 2025
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