The U.S. Food and Drug Administration (FDA) is cautioning dentists about purchasing or using handheld dental X-ray units manufactured outside of the U.S. that do not bear the proper FDA labeling. The FDA statement says the agency is “concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays. The units, sold online by manufacturers outside the United States and directly shipped to U.S. customers, have not been reviewed by the FDA and do not meet FDA radiation safety requirements.”
To date, no adverse events have been reported through use of these units, according to the FDA.
All FDA-approved handheld X-ray units bear a permanent certification label/tag, a warning label, and an identification label / tag on the unit. To ensure that a device has been cleared by the FDA, users are advised to:
• Verify the presence of required labels on the device,
• Ask vendors whether the device has been reviewed and cleared by the FDA,
• Access the FDA Medical Device Approvals and Clearances database to verify that the X-ray unit has been cleared by the FDA, and
• Contact a regulatory agency if they become aware of an unsafe device or one that does not meet FDA requirements.