Cleared Special

ACCLAIM

K042266 · Air Techniques, Inc. · Dental

Aug 2004

Decision

Days

Class 1

Risk

About This 510(k) Submission

K042266 is an FDA 510(k) clearance for the ACCLAIM, a Unit, Operative Dental, Accessories (Class I — General Controls, product code NRD), submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on August 31, 2004, 8 days after receiving the submission on August 23, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K042266 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2004
Decision Date	August 31, 2004
Days to Decision	8 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Statement

Device Classification

Product Code	NRD — Unit, Operative Dental, Accessories
Device Class	Class I — General Controls
CFR Regulation	21 CFR 872.6640
Definition	Air Compressor And Vacuum Unit That Are Connected To Dental Operative Unit To Provide Compressed Air And Vacuum Capability To Power And Drive Other Dental Devices, Which Are Attached To The Dental Operative Unit.