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Hand-held Dental X-ray Unit

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Hand-held Dental X-ray Unit

In order to be legally marketed in the United States, hand-held dental X-ray units must comply with FDA’s radiation safety and medical device requirements.

Manufacturers of these devices must submit a Premarket Notification 510(k) for evaluation by the FDA for safety and effectiveness before the product is cleared for sale in the United States, unless exempt.

Also, manufacturers of these devices are required to register annually with the FDA in addition to other requirements.

Certification & Labeling

Hand-held dental X-ray units that have been certified by the manufacturer to meet the FDA’s radiation safety standards bear a certification label or tag, a warning label, and an identification (ID) label or tag on the unit’s housing.

All labels/tags should be in the English language and permanently affixed or inscribed on each product so that they are legible and readily accessible when the X-ray unit is fully assembled for use.

The Certification Label should state: “This product complies with 21 CFR 1020.30 – 1020.31”“This product complies with 21 CFR Subchapter J” or other similar language.

The Warning Label must be on the x-ray panel of the unit and state 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.”

Finally, the Identification (ID) Label must contain:

1

Full name and address of the manufacturer of the unit.

2

Place of manufacture.

3

Month and year of manufacture.

Illegal Sale of Potentially Unsafe Medical Devices

The FDA is aware of hand-held dental X-ray units that do not meet these requirements, but being sold online by manufacturers outside the U.S. and directly shipped to customers in the U.S.

To ensure that you purchase and use hand-held dental X-ray units reviewed and tested to meet the FDA’s standards for radiation-emitting electronic products:

  1. Verify that your device bears certification, warning and ID labels as described above.
  2. Ask your vendor whether the device has been reviewed and cleared by the FDA.
  3. Access the FDA Medical Device Approvals and Clearances searchable database to verify that the X-ray unit you are using has been reviewed by the FDA.
Common Dental X-ray Medical Devices

Dental X-Ray Exposure Alignment Device
Aligner, Beam, X-Ray
Product Code: EHA
Submission Type: Premarket Notification 510(K) Exempt
Regulation Number: 872.1820
Device Class: 1
GMP Exempt: No
Summary Malfunction Reporting: Eligible

Dental X-Ray Position Indicating Device
Collimator, X-Ray
Product Code: EHB
Submission Type: Premarket Notification 510(K) Exempt
Regulation Number: 872.1840
Device Class: 1
GMP Exempt: No
Summary Malfunction Reporting: Eligible

Dental X-Ray Film Holder
Holder, Film, X-Ray
Product Code: EGZ
Submission Type: Premarket Notification 510(K) Exempt
Regulation Number: 872.1905
Device Class: 1
GMP Exempt: Yes
This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Summary Malfunction Reporting: Eligible

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If you become aware of a device that you think is hazardous or does not meet FDA’s radiation safety or premarket clearance requirements, contact your state regulatory agency, which will then notify the FDA.

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