Cleared Traditional

Q-LUX PLASMA 100 LIGHT CURE UNIT (K001719) - FDA 510(k) Clearance

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

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.

View all Rolence Enterprise Co. , Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 127d · This submission: 127d
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 36
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K001719.
Le'Pen
K181597 · Kmihh, Ltd. · Apr 2019
Dr's Light2
K173157 · Good Doctors Co., Ltd. · May 2018
Cybird LED Curing Light
K173876 · Dxm Co., Ltd. · Jan 2018
3M AURORA SYSTEM
K972355 · 3M Company · Aug 1997
SPECTRUM CURING LIGHT POLYMERIZATION UNIT
K951425 · Dentsply Intl. · May 1995
3M CURING LIGHT XL1500
K934746 · 3M Company · Jan 1994