Cleared Traditional

K023721 - BONART ART-L2 LIGHT CURING UNIT

K023721 is an FDA 510(k) clearance for BONART ART-L2 LIGHT CURING UNIT, 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 66-day FDA review.

K023721 · Bonart Co., Ltd. · Dental device
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Jan 2003
Decision
66d
Days
Class 2
Risk

K023721 is an FDA 510(k) clearance for the BONART ART-L2 LIGHT CURING UNIT. 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 January 10, 2003 after a review of 66 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 - K023721

510(k) Number K023721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2002
Decision Date January 10, 2003
Days to Decision 66 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
62d faster than avg
Panel avg: 128d · This submission: 66d
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 K023721.
RADII
K030568 · Southern Dental Industries, Inc. · Apr 2003
RMO PLASMA CURING LIGHT
K024374 · Lokki Lasers Medicaux · Mar 2003
FLASH-LITE II LED DENTAL CURING LIGHT
K023748 · Discus Dental, Inc. · Jan 2003
REMECURE MODEL CL 15E
K023652 · Remedent NV · Jan 2003
ULTRA-LITE 200E LIGHT CURE UNIT
K023545 · Rolence Ent., Inc. · Dec 2002
TRANSCURE, MODEL 2910
K022862 · Kinetic Instruments, Inc. · Oct 2002