Cleared Traditional

K950175 - THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) (FDA 510(k) Clearance)

Class I Dental device.

K950175 · Aqua-Air Medical Devices, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
91d
Days
Class 1
Risk

K950175 is an FDA 510(k) clearance for the THE AQUA-AIR PROFESSIONAL FIELD UNIT(S). Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Aqua-Air Medical Devices, Inc. (Miami, US). The FDA issued a Cleared decision on April 18, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Aqua-Air Medical Devices, Inc. devices

Submission Details

510(k) Number K950175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date April 18, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.

Regulatory Peers - EIA Unit, Operative Dental

All 283
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