Cleared Traditional

K880392 - ORTHOLUX VISIBLE LIGHT CURING UNIT

K880392 is the FDA 510(k) clearance for ORTHOLUX VISIBLE LIGHT CURING UNIT by Unitek Corp.. It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K880392 · Unitek Corp. · Dental device
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Apr 1988
Decision
69d
Days
Class 2
Risk

K880392 is an FDA 510(k) clearance for the ORTHOLUX VISIBLE LIGHT CURING UNIT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on April 7, 1988 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.

View all Unitek Corp. devices

Submission Details

510(k) Number K880392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1988
Decision Date April 07, 1988
Days to Decision 69 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 127d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 81
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K880392.
TULUX-FILTER
K892517 · Espe GmbH (Us) · Aug 1989
KULZER TRANSLUX EC
K892456 · Kulzer, Inc. · Jun 1989
PHOTO-CURING LIGHT
K882145 · Dentsply Intl. · Sep 1988
TRANSLUX CL
K843823 · Kulzer, Inc. · Dec 1984
PRISMA III
K832320 · Dentsply Intl. · Aug 1983
KULZER TRANSLUX VISIBLE LIGHT CURING
K811668 · Kulzer, Inc. · Jul 1981