Cleared Traditional

K964524 - ILT ARGON HP

K964524 is an FDA 510(k) clearance for ILT ARGON HP, manufactured by Ion Laser Technology. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K964524 · Ion Laser Technology · Dental device
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Mar 1997
Decision
126d
Days
Class 2
Risk

K964524 is an FDA 510(k) clearance for the ILT ARGON HP. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Ion Laser Technology (Salt Lake City, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ion Laser Technology devices

FDA 510(k) Submission Details - K964524

510(k) Number K964524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1996
Decision Date March 18, 1997
Days to Decision 126 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
1d faster than avg
Panel avg: 127d · This submission: 126d
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 103
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K964524.
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K970506 · Benlioglu Dental Ithalat, Inc. · Jun 1997
JETLITE
K963110 · J. Morita USA, Inc. · Oct 1996
ACTA
K961735 · Satelec · Jul 1996
COLTOLUX 3, COLTOLUX 4
K945698 · Coltene/Whaledent, Inc. · May 1995