Cleared Traditional

K981144 - CLEAN SOURCE I, MODEL CS1000

K981144 is an FDA 510(k) clearance for CLEAN SOURCE I, manufactured by Aquarius Technologies, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K981144 · Aquarius Technologies, Inc. · Dental device
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Sep 1998
Decision
169d
Days
Class 1
Risk

K981144 is an FDA 510(k) clearance for the CLEAN SOURCE I, MODEL CS1000. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Aquarius Technologies, Inc. (Longmont, US). The FDA issued a Cleared decision on September 15, 1998 after a review of 169 days - an extended review 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: 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 Aquarius Technologies, Inc. devices

FDA 510(k) Submission Details - K981144

510(k) Number K981144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1998
Decision Date September 15, 1998
Days to Decision 169 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
42d slower than avg
Panel avg: 127d · This submission: 169d
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 123
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K981144.
BIOCLEAR CONCENTRATE
K981565 · Waggoner Product Development · Oct 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
ULTRACAM
K973410 · W. Edward Johansen · Oct 1998
FLUID CONTROL
K982117 · T.A. Coleman Ent. · Sep 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
K981937 · Welch Allyn, Inc. · Aug 1998
BONETRAP
K980049 · Bladhs Plast AB · Aug 1998