Cleared Traditional

ESG-1 ELECTROSONOGRAM (ESG-1) (K970116) - FDA 510(k) Clearance

Class I Dental device.

K970116 · Myo-Tronics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
79d
Days
Class 1
Risk

K970116 is an FDA 510(k) clearance for the ESG-1 ELECTROSONOGRAM (ESG-1). Classified as Device, Dental Sonography, For Monitoring Jaw Sounds (product code NFQ), Class I - General Controls.

Submitted by Myo-Tronics, Inc. (Tukwila, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 79 days - a notably fast clearance cycle.

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

View all Myo-Tronics, Inc. devices

Submission Details

510(k) Number K970116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1997
Decision Date April 02, 1997
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
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.