Cleared Traditional

K050059 - G-LIGHT

K050059 is an FDA 510(k) clearance for G-LIGHT, manufactured by GC America, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K050059

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.

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 144
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K050059.
SKYLIGHT LED CURING LIGHT
K051571 · Dmetec.Co., Ltd. · Jul 2005
L.E. DEMETRON II
K051545 · Kerr Corporation (Danbury) · Jul 2005
BLUELEX
K051203 · Monitex Industrial Co., Ltd. · May 2005
DVI CURING LIGHT
K043530 · Designs For Vision, Inc. · Jan 2005
NOVA-PULSE
K043302 · Nova Ranger, Inc. · Jan 2005
DEMETRON IDS CURING LIGHT
K042888 · Kerr Corp. · Nov 2004