Cleared Traditional

DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (K001493) - FDA 510(k) Clearance

Class I Dental device.

K001493 · Air Force, Inc. · Dental device
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Oct 2000
Decision
166d
Days
Class 1
Risk

K001493 is an FDA 510(k) clearance for the DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Air Force, Inc. (Holland, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 166 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6510 - 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 Force, Inc. devices

Submission Details

510(k) Number K001493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2000
Decision Date October 25, 2000
Days to Decision 166 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
39d slower than avg
Panel avg: 127d · This submission: 166d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFS Unit, Oral Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6510
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.