Cleared Traditional

K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 (K944134) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944134 · Myo-Tronics, Inc. · Dental device
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Dec 1994
Decision
107d
Days
Class 2
Risk

K944134 is an FDA 510(k) clearance for the K6-1 DIAGNOSTIC SYSTEM VERSION 3.1. Classified as Device, Muscle Monitoring (product code KZM), Class II - Special Controls.

Submitted by Myo-Tronics, Inc. (Tukwila, US). The FDA issued a Cleared decision on December 9, 1994 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.1375 - 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 Myo-Tronics, Inc. devices

Submission Details

510(k) Number K944134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1994
Decision Date December 09, 1994
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 127d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KZM Device, Muscle Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.