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Some Handheld Dental X-Ray Units Being Sold Without Required FDA Certification

February 25, 2013

The U.S. Food and Drug Administration (FDA) has issued an alert that some handheld dental x-ray units purchased online and shipped directly from vendors in Southeast Asia may not meet U.S. regulatory standards. If your office purchased a handheld dental x-ray unit through a credible U.S.-based vendor, this alert should not be of concern.

To confirm whether your handheld dental x-ray unit meets standards, you are encouraged to check that your unit has all the required radiation safety labeling, which includes a certification label, a warning label and an identification label. The certification label should state: “This product complies with 21 CFR 1020.30 - 1020.31,” “This product complies with 21 CFR Subchapter J” or similar language. The warning label must appear on the x-ray panel of the unit and contain these exact words: “This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed.” The identification (id) label must contain the full name and address of the manufacturer of the unit, the place of manufacture, and the month and year of manufacture.

If your device does not contain this required labeling, you should contact the x-ray unit of the Colorado Department of Public Health and Environment at 303-692-3427.

Please exercise caution in purchasing handheld dental x-ray units, especially when purchasing a device online. Prior to purchasing, be sure to ask your vendor if the x-ray unit has been reviewed by the U.S. FDA and met its requirements.


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