Cleared Traditional

K001719 - Q-LUX PLASMA 100 LIGHT CURE UNIT

K001719 is an FDA 510(k) clearance for Q-LUX PLASMA 100 LIGHT CURE UNIT, manufactured by Rolence Enterprise Co. , Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K001719 · Rolence Enterprise Co. , Ltd. · Dental device
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Oct 2000
Decision
127d
Days
Class 2
Risk

K001719 is an FDA 510(k) clearance for the Q-LUX PLASMA 100 LIGHT CURE UNIT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Rolence Enterprise Co. , Ltd. (Chungli 320, TW). The FDA issued a Cleared decision on October 10, 2000 after a review of 127 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K001719

510(k) Number K001719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2000
Decision Date October 10, 2000
Days to Decision 127 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
1d faster than avg
Panel avg: 128d · This submission: 127d
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 202
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K001719.
COOLBLU CURING LIGHT
K002925 · Dental Systems.Com, Inc. · Dec 2000
ZAP DUAL CURING LIGHT
K002991 · Soft-Core Texas, Inc. · Nov 2000
LUMALITE CURE LIGHT, MODEL 2100
K002566 · Lumalite, Inc. · Oct 2000
JETLITE 4000
K000078 · J. Morita USA, Inc. · May 2000
VIP- VARIABLE INTENSITY POLYMERIZER
K000426 · Bisco, Inc. · Apr 2000
NOVA CORDLESS CURING LIGHT
K000393 · Nova/Da Vinci Systems, Inc. · Mar 2000
K001719 · Q-LUX PLASMA 100 LIGHT CURE UNIT
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