Cleared Traditional

AIR TECHNIQUES' AIRDENT II

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

About This 510(k) Submission

K981564 is an FDA 510(k) clearance for the AIR TECHNIQUES' AIRDENT II, a Airbrush (Class II — Special Controls, product code KOJ), submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on September 24, 1998, 146 days after receiving the submission on May 1, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.6080.

Submission Details

510(k) Number K981564 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KOJ — Airbrush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6080