Cleared Traditional

K823133 - AIR FLOW I

K823133 is an FDA 510(k) clearance for AIR FLOW I, manufactured by Healthco, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K823133 · Healthco, Inc. · Dental device
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Nov 1982
Decision
23d
Days
Class 1
Risk

K823133 is an FDA 510(k) clearance for the AIR FLOW I. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Healthco, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 17, 1982 after a review of 23 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K823133

510(k) Number K823133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1982
Decision Date November 17, 1982
Days to Decision 23 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 128d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

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 272
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K823133.
SATELEC PROPHY UNIT PU-2000
K832673 · Spelna, Inc. · Oct 1983
STERILE WATER SYSTEM
K823230 · Syntex Dental Products, Inc. · Dec 1982
SA-21 DENTAL UNIT
K823180 · Ritter Co. · Nov 1982
PORT-OP
K813106 · Portec, Inc. · Nov 1981
SPACELINE DENTAL CHAIR-UNIT
K801685 · Pacific Dental Corp. · Aug 1980
MOBILE UNITS, I,II,III,IV
K790112 · Dentsply Intl. · Feb 1979
K823133 · AIR FLOW I
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