Cleared Traditional

BNS 40 (K842224) - FDA 510(k) Clearance

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

K842224 · Myo-Tronics Research, Inc. · Dental device
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Nov 1984
Decision
167d
Days
Class 2
Risk

K842224 is an FDA 510(k) clearance for the BNS 40. 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 November 19, 1984 after a review of 167 days - an extended review 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: 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 Research, Inc. devices

Submission Details

510(k) Number K842224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1984
Decision Date November 19, 1984
Days to Decision 167 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 127d · This submission: 167d
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.