Cleared Traditional

MONITOR, MYO, MODEL J3 (K770252) - FDA 510(k) Clearance

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

K770252 · Myo-Tronics Research, Inc. · Dental device
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Feb 1977
Decision
9d
Days
Class 2
Risk

K770252 is an FDA 510(k) clearance for the MONITOR, MYO, MODEL J3. Classified as Stimulator, Muscle, Powered, Dental (product code NUW), Class II - Special Controls.

Submitted by Myo-Tronics Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 18, 1977 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.5850 - 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 Research, Inc. devices

Submission Details

510(k) Number K770252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1977
Decision Date February 18, 1977
Days to Decision 9 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 127d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUW Stimulator, Muscle, Powered, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
Definition Relief Of Muscle Spasms Associated With Tmj. Muscle Reeducation, Increasing Blood Flow.
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.