Cleared Traditional

K964271 - IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID

K964271 is an FDA 510(k) clearance for IGN 500 TM WATER CLEANING UNIT WITH CAL..., manufactured by Airel-West. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 420-day FDA review.

K964271 · Airel-West · Dental device
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Dec 1997
Decision
420d
Days
Class 1
Risk

K964271 is an FDA 510(k) clearance for the IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Airel-West (Washington, US). The FDA issued a Cleared decision on December 19, 1997 after a review of 420 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Airel-West devices

FDA 510(k) Submission Details - K964271

510(k) Number K964271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1996
Decision Date December 19, 1997
Days to Decision 420 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
293d slower than avg
Panel avg: 127d · This submission: 420d
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 170
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K964271.
CLEARLINE PLUS, DENTAL WATERLINE FILTER
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VISTACAM OMNI AND VIASTCAM OMNI (IC)
K974204 · Air Techniques, Inc. · Jan 1998
DENTALVIEW PERIOVIEW SYSTEM
K973492 · Dentalview, Inc. · Oct 1997
VIOLA II DENTAL CAMERA SYSTEM
K973035 · Innovative Medical Systems, Inc. · Sep 1997
DCI WATER PURIFIER
K971727 · Dental Components, Inc. · Sep 1997