Cleared Special

ACCLAIM (K042266) - FDA 510(k) Clearance

Class I Dental device.

K042266 · Air Techniques, Inc. · Dental device
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Aug 2004
Decision
8d
Days
Class 1
Risk

K042266 is an FDA 510(k) clearance for the ACCLAIM. Classified as Unit, Operative Dental, Accessories (product code NRD), Class I - General Controls.

Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on August 31, 2004 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Air Techniques, Inc. devices

Submission Details

510(k) Number K042266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 127d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NRD Unit, Operative Dental, Accessories
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.