Cleared Traditional

K960364 - CU-200 LIGHT CURE UNIT

K960364 is an FDA 510(k) clearance for CU-200 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 81-day FDA review.

K960364 · Rolence Enterprise Co. , Ltd. · Dental device
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Apr 1996
Decision
81d
Days
Class 2
Risk

K960364 is an FDA 510(k) clearance for the CU-200 LIGHT CURE UNIT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Rolence Enterprise Co. , Ltd. (Chungli, Taiwan, TW). The FDA issued a Cleared decision on April 15, 1996 after a review of 81 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 - K960364

510(k) Number K960364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date April 15, 1996
Days to Decision 81 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
47d faster than avg
Panel avg: 128d · This submission: 81d
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 K960364.
JETLITE
K963110 · J. Morita USA, Inc. · Oct 1996
ACTA
K961735 · Satelec · Jul 1996
Q-LUX LIGHT CURE UNIT
K960351 · Rolence Enterprise Co. , Ltd. · Apr 1996
ACL-5500 PRECISION CURING UNIT (PCU)
K953898 · Ion Laser Technology · Feb 1996
OPTILUX 400
K955763 · Demetron Research Corp. · Jan 1996
LITEX 680
K955759 · Dentamerica · Jan 1996
K960364 · CU-200 LIGHT CURE UNIT
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