Cleared Traditional

K982615 - AIRDENT RADIANCE CURING LIGHT

K982615 is the FDA 510(k) clearance for AIRDENT RADIANCE CURING LIGHT by Air Techniques, Inc.. It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K982615 · Air Techniques, Inc. · Dental device
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Aug 1998
Decision
28d
Days
Class 2
Risk

K982615 is an FDA 510(k) clearance for the AIRDENT RADIANCE CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on August 24, 1998 after a review of 28 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 Air Techniques, Inc. devices

Submission Details

510(k) Number K982615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date August 24, 1998
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
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 65
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K982615.
AVANTE CURELIGHT
K003683 · Jeneric/Pentron, Inc. · Jan 2001
JETLITE 4000
K000078 · J. Morita USA, Inc. · May 2000
VIP- VARIABLE INTENSITY POLYMERIZER
K000426 · Bisco, Inc. · Apr 2000
3M AURORA SYSTEM
K972355 · 3M Company · Aug 1997
JETLITE
K963110 · J. Morita USA, Inc. · Oct 1996
SPECTRUM CURING LIGHT POLYMERIZATION UNIT
K951425 · Dentsply Intl. · May 1995