Cleared Traditional

K974369 - APOLLO 9500

K974369 is an FDA 510(k) clearance for APOLLO 9500, 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 47-day FDA review.

K974369 · Ion Laser Technology · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
47d
Days
Class 2
Risk

K974369 is an FDA 510(k) clearance for the APOLLO 9500. 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 January 6, 1998 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 Ion Laser Technology devices

FDA 510(k) Submission Details - K974369

510(k) Number K974369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1997
Decision Date January 06, 1998
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 103
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K974369.
VIP- VARIABLE INTENSITY POLYMERIZER
K000426 · Bisco, Inc. · Apr 2000
ELIPAR TRILIGHT
K984247 · Espe Dental AG · Feb 1999
AIRDENT RADIANCE CURING LIGHT
K982615 · Air Techniques, Inc. · Aug 1998
3M AURORA SYSTEM
K972355 · 3M Company · Aug 1997
ACTA OEM MODULE
K972006 · Interactive Consulting, Inc. · Jul 1997
HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT
K970506 · Benlioglu Dental Ithalat, Inc. · Jun 1997