The FDA safety communication advises dental professionals to avoid using certain hand-held dental x-ray units. According to the FDA, these hand-held devices could expose the patient to unnecessary and potentially harmful X-rays. The units are sold online by manufacturers outside the U.S. and shipped directly to the dentist and have not been reviewed by the FDA and do not meet FDA radiation safety requirements.
If your dentist is using one of these devises to x-ray your mouth you need make a serious inquiry into whether or not the device has been approved by the FDA and corresponding state regulatory agencies. You might want to consider a new dentist, asking yourself why your health care professional isn’t using a standard wall mounted unit. Is your dentist trying to skirt the law and its requirements that attempt to insure your safety?
All of the units that have been cleared by the FDA bear a permanent certification label/tag, a warning label and identification label/tag on the unit. If not, then run. You don’t want this dentist treating your oral healthcare needs. There are too many ‘good’ dentists who truly care about your health.
The Washington State Department of Health alerted the FDA after tests on a device purchased online revealed it did not comply with X-ray performance standards. FDA is investigating and will continue to monitor the problem.
For now questions can be directed to the Division of Small Manufacturers, International and Consumer Assistance at DSMICA@FDA.HHS.GOV, 1-800-638-2041 or 1-301-796-7100. If we can be of service or answer any of questions feel free to call us or contact us via email.
Novy Scheinfeld, DDS, PC.
5471 Bells Ferry Road, Suite 200
Acworth, GA 30102
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