Cleared Traditional

K020874 - ULTRA-LITE 5 TURBO LIGHT CURE UNIT

K020874 is an FDA 510(k) clearance for ULTRA-LITE 5 TURBO 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 86-day FDA review.

K020874 · Rolence Ent., Inc. · Dental device
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Jun 2002
Decision
86d
Days
Class 2
Risk

K020874 is an FDA 510(k) clearance for the ULTRA-LITE 5 TURBO 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 June 12, 2002 after a review of 86 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 - K020874

510(k) Number K020874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date June 12, 2002
Days to Decision 86 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
42d faster than avg
Panel avg: 128d · This submission: 86d
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 K020874.
PALMLIGHT
K020057 · CAO Group, Inc. · Aug 2002
FLASH-LITE LED DENTAL CURING LIGHT
K022184 · Discus Dental, Inc. · Aug 2002
L.E.DEMETRON
K021797 · Sybron Dental Specialties, Inc. · Jun 2002
EXCELLITE TURBO LIGHT CURE UNIT
K020877 · Rolence Ent., Inc. · Jun 2002
EXCELLITE LIGHT CURE UNIT
K020884 · Rolence Ent., Inc. · Jun 2002
TOESCO AQUA BLUE LED LIGHT CURING DEVICE
K021374 · Toei Electric Co., Ltd. · May 2002
K020874 · ULTRA-LITE 5 TURBO LIGHT CURE UNIT
Download PDF Rolence Ent., Inc.