Cleared Traditional

K023545 - ULTRA-LITE 200E LIGHT CURE UNIT

K023545 is an FDA 510(k) clearance for ULTRA-LITE 200E LIGHT CURE UNIT, manufactured by Rolence Ent., Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K023545 · Rolence Ent., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
69d
Days
Class 2
Risk

K023545 is an FDA 510(k) clearance for the ULTRA-LITE 200E LIGHT CURE UNIT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Rolence Ent., Inc. (Chungli, TW). The FDA issued a Cleared decision on December 30, 2002 after a review of 69 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 - K023545

510(k) Number K023545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2002
Decision Date December 30, 2002
Days to Decision 69 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
59d faster than avg
Panel avg: 128d · This submission: 69d
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 202
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K023545.
FLASH-LITE II LED DENTAL CURING LIGHT
K023748 · Discus Dental, Inc. · Jan 2003
BONART ART-L2 LIGHT CURING UNIT
K023721 · Bonart Co., Ltd. · Jan 2003
REMECURE MODEL CL 15E
K023652 · Remedent NV · Jan 2003
TRANSCURE, MODEL 2910
K022862 · Kinetic Instruments, Inc. · Oct 2002
LIGHT TIP
K022265 · Svenska Dental Instruments AB · Oct 2002
PALMLIGHT
K020057 · CAO Group, Inc. · Aug 2002
K023545 · ULTRA-LITE 200E LIGHT CURE UNIT
Download PDF Rolence Ent., Inc.