Cleared Traditional

K050059 - G-LIGHT

K050059 is the FDA 510(k) clearance for G-LIGHT by GC America, Inc.. It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K050059 · GC America, Inc. · Dental device
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Feb 2005
Decision
23d
Days
Class 2
Risk

K050059 is an FDA 510(k) clearance for the G-LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on February 3, 2005 after a review of 23 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 GC America, Inc. devices

Submission Details

510(k) Number K050059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2005
Decision Date February 03, 2005
Days to Decision 23 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
104d faster than avg
Panel avg: 127d · This submission: 23d
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 64
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K050059.
BISCO LED
K052122 · Bisco, Inc. · Mar 2006
BLUEPHASE 16I
K051782 · Ivoclar Vivadent, Inc. · Sep 2005
JETLITE 5000
K051780 · J. Morita USA, Inc. · Jul 2005
BLUEPHASE
K033520 · Ivoclar Vivadent, Inc. · Dec 2003
L.E.DEMETRON
K021797 · Sybron Dental Specialties, Inc. · Jun 2002
OPTILUX CURING LIGHTS
K020267 · Sybron Dental Specialties, Inc. · Mar 2002