Cleared Traditional

ILT ARGON HP (K964524) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964524 · Ion Laser Technology · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 36
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K964524.
Dr's Light2
K173157 · Good Doctors Co., Ltd. · May 2018
Cybird LED Curing Light
K173876 · Dxm Co., Ltd. · Jan 2018
3M AURORA SYSTEM
K972355 · 3M Company · Aug 1997
SPECTRUM CURING LIGHT POLYMERIZATION UNIT
K951425 · Dentsply Intl. · May 1995
3M CURING LIGHT XL1500
K934746 · 3M Company · Jan 1994
ORTHOLUX XT
K930086 · 3M Company · Apr 1993