Cleared Traditional

K002566 - LUMALITE CURE LIGHT, MODEL 2100

K002566 is an FDA 510(k) clearance for LUMALITE CURE LIGHT, manufactured by Lumalite, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K002566 · Lumalite, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
63d
Days
Class 2
Risk

K002566 is an FDA 510(k) clearance for the LUMALITE CURE LIGHT, MODEL 2100. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Lumalite, Inc. (Spring Valley, US). The FDA issued a Cleared decision on October 19, 2000 after a review of 63 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 Lumalite, Inc. devices

FDA 510(k) Submission Details - K002566

510(k) Number K002566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2000
Decision Date October 19, 2000
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
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 127
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K002566.
VERSALUX
K010133 · Centrix, Inc. · Apr 2001
PALMLIGHT
K003383 · Ultradent Products, Inc. · Feb 2001
AVANTE CURELIGHT
K003683 · Jeneric/Pentron, Inc. · Jan 2001
JETLITE 4000
K000078 · J. Morita USA, Inc. · May 2000
VIP- VARIABLE INTENSITY POLYMERIZER
K000426 · Bisco, Inc. · Apr 2000
PORTABLE LIGHT CURING UNIT
K994048 · Gregory S. Jacob, D.D.S. · Jan 2000