Cleared Traditional

BIOSONIC ULTRASONIC CLEANING SYSTEM (K884660) - FDA 510(k) Clearance

Class I General Hospital device.

K884660 · Whaledent Intl. Div. Ipco · General Hospital
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Mar 1989
Decision
129d
Days
Class 1
Risk

K884660 is an FDA 510(k) clearance for the BIOSONIC ULTRASONIC CLEANING SYSTEM. Classified as Cleaner, Ultrasonic, Medical Instrument (product code FLG), Class I - General Controls.

Submitted by Whaledent Intl. Div. Ipco (Hartsdale, US). The FDA issued a Cleared decision on March 16, 1989 after a review of 129 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6150 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Whaledent Intl. Div. Ipco devices

Submission Details

510(k) Number K884660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1988
Decision Date March 16, 1989
Days to Decision 129 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 129d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FLG Cleaner, Ultrasonic, Medical Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6150
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.