Cleared Traditional

K991863 - CUTE-LITE I LIGHT CURE UNIT

K991863 is an FDA 510(k) clearance for CUTE-LITE I LIGHT CURE UNIT, manufactured by Rolence Enterprise Co. , Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K991863 · Rolence Enterprise Co. , Ltd. · Dental device
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Jul 1999
Decision
48d
Days
Class 2
Risk

K991863 is an FDA 510(k) clearance for the CUTE-LITE I LIGHT CURE UNIT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Rolence Enterprise Co. , Ltd. (Chungli 320, TW). The FDA issued a Cleared decision on July 19, 1999 after a review of 48 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 Rolence Enterprise Co. , Ltd. devices

FDA 510(k) Submission Details - K991863

510(k) Number K991863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1999
Decision Date July 19, 1999
Days to Decision 48 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
79d faster than avg
Panel avg: 127d · This submission: 48d
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 108
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K991863.
EASY-CURE (CURING AND WHITENING LIGHT)
K992357 · Ics of North America, Inc. · Aug 1999
LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA
K992236 · Lysta A/S · Aug 1999
Q-LITE 75 LIGHT CURE UNIT
K991865 · Rolence Enterprise Co. , Ltd. · Jul 1999
LYSTA LC CURING LIGHT, MODEL LC 2500C/BA
K991138 · Lysta A/S · Apr 1999
ELIPAR TRILIGHT
K984247 · Espe Dental AG · Feb 1999
AIRDENT RADIANCE CURING LIGHT
K982615 · Air Techniques, Inc. · Aug 1998