Cleared Traditional

K994028 - FLIPO XENON CURING LIGHT

K994028 is an FDA 510(k) clearance for FLIPO XENON CURING LIGHT, manufactured by Lokki. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K994028 · Lokki · Dental device
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Jan 2000
Decision
47d
Days
Class 2
Risk

K994028 is an FDA 510(k) clearance for the FLIPO XENON CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Lokki (Centercille, US). The FDA issued a Cleared decision on January 12, 2000 after a review of 47 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 Lokki devices

FDA 510(k) Submission Details - K994028

510(k) Number K994028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date January 12, 2000
Days to Decision 47 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
80d faster than avg
Panel avg: 127d · This submission: 47d
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 126
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K994028.
JETLITE 4000
K000078 · J. Morita USA, Inc. · May 2000
VIP- VARIABLE INTENSITY POLYMERIZER
K000426 · Bisco, Inc. · Apr 2000
PORTABLE LIGHT CURING UNIT
K994048 · Gregory S. Jacob, D.D.S. · Jan 2000
RAPICURE 200 (CURING AND WHITENING LIGHT)
K993223 · Mediphotonix, LC · Nov 1999
SPRING POWERLITE 2000
K992728 · Spring Health Products, Inc. · Sep 1999
EASY-CURE (CURING AND WHITENING LIGHT)
K992357 · Ics of North America, Inc. · Aug 1999