Cleared Traditional

K091887 - LED CURING LIGHT

K091887 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 86-day FDA review.

K091887 · Monitex Industrial Co., Ltd. · Dental device
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Sep 2009
Decision
86d
Days
Class 2
Risk

K091887 is an FDA 510(k) clearance for the LED CURING LIGHT, MODEL GT-1500. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Monitex Industrial Co., Ltd. (San-Chung City, TW). The FDA issued a Cleared decision on September 18, 2009 after a review of 86 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 Monitex Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K091887

510(k) Number K091887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2009
Decision Date September 18, 2009
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 98
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K091887.
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