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Sonogram, Kinesiograph TMD Devices Should Be Class I With 510(k) -Panel

This article was originally published in The Gray Sheet

Executive Summary

Sonogram and kinesiograph temporomandibular joint (TMJ) devices should be classified as Class I, but are of sufficient concern to warrant submission of a 510(k), FDA's Dental Products Panel unanimously recommended (7-0) at an Aug. 5 meeting.

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