Cleared Traditional

SONOPAK/QS, SONOPAK (K905657) - FDA 510(k) Clearance

Class I Dental device.

K905657 · Bioresearch · Dental device
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May 1991
Decision
149d
Days
Class 1
Risk

K905657 is an FDA 510(k) clearance for the SONOPAK/QS, SONOPAK. Classified as Device, Dental Sonography, For Monitoring Jaw Sounds (product code NFQ), Class I - General Controls.

Submitted by Bioresearch (Milwaukee, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.2050 - 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.

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Submission Details

510(k) Number K905657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1990
Decision Date May 15, 1991
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NFQ Device, Dental Sonography, For Monitoring Jaw Sounds
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.2050
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.