Cleared Traditional

K981564 - AIR TECHNIQUES' AIRDENT II

K981564 is the FDA 510(k) clearance for AIR TECHNIQUES' AIRDENT II by Air Techniques, Inc.. It is a Class 2 Dental device (product code KOJ) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K981564 · Air Techniques, Inc. · Dental device
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Sep 1998
Decision
146d
Days
Class 2
Risk

K981564 is an FDA 510(k) clearance for the AIR TECHNIQUES' AIRDENT II. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on September 24, 1998 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6080 - 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 Air Techniques, Inc. devices

Submission Details

510(k) Number K981564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1998
Decision Date September 24, 1998
Days to Decision 146 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
19d slower than avg
Panel avg: 127d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOJ Airbrush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6080
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 - KOJ Airbrush

All 7
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K981564.
turbodent touch
K251425 · Mectron S.P.A. · May 2025
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675 · Sirona Dental Systems GmbH · Jan 2004
NEW PROPHY POWDER
K014188 · Dentsply Intl. · Mar 2002
ULTRA-BLASTER
K980726 · Ultradent Products, Inc. · May 1998
AEROETCHER
K973679 · Parkell, Inc. · Mar 1998
ACCU-PREP
K970484 · Bisco, Inc. · Jul 1997