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.