Cleared Traditional

K082971 - BONART ART-L5 LED CORDLESS CURING LIGHT

K082971 is an FDA 510(k) clearance for BONART ART-L5 LED CORDLESS CURING LIGHT, manufactured by Bonart Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K082971 · Bonart Co., Ltd. · Dental device
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Nov 2008
Decision
38d
Days
Class 2
Risk

K082971 is an FDA 510(k) clearance for the BONART ART-L5 LED CORDLESS CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Bonart Co., Ltd. (Walnut, US). The FDA issued a Cleared decision on November 13, 2008 after a review of 38 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.

FDA 510(k) Submission Details - K082971

510(k) Number K082971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2008
Decision Date November 13, 2008
Days to Decision 38 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
90d faster than avg
Panel avg: 128d · This submission: 38d
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 195
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K082971.
VALO, MODEL 5919
K083647 · Ultradent Products, Inc. · Jan 2009
LEDEX, MODEL: WL-070
K082408 · Dentmate Technology Co. , Ltd. · Dec 2008
SAPPHIRE PLASMA ARC DENTAL CURING LIGHT
K081287 · Den-Mat Holdings, LLC · Nov 2008
LED.L, LED.M, LED.G, LED.B
K080025 · Guilin Woodpecker Medical Instrument Co., Ltd. · Mar 2008
LED CURING LIGHT
K080035 · Monitex Industrial Co., Ltd. · Mar 2008
FLASHLITE REBEL*
K073518 · Discus Dental, Inc. · Dec 2007