In Brief: Dental/Medical Diagnostic Systems
This article was originally published in The Gray Sheet
Executive Summary
Dental/Medical Diagnostic Systems: Firm will be allowed to continue selling its TeliCam intraoral dental camera in domestic and international markets pending 510(k) clearance from FDA, the company says. The agency is requiring all manufacturers of intraoral cameras to obtain 510(k)s, according to the firm. Although Dental/Medical disagrees with FDA's decision to require the company to submit a 510(k) for the TeliCam, "the company has determined to promptly comply" with the agency's request...