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Evaluation of Safety Concerns with Certain Dental Devices Used on Adults – FDA Safety Communication
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to inform patients, caregivers, and health care providers about our evaluation of safety concerns with the use of certain dental devices, specifically fixed (non-removable) palatal expanders used on adults to remodel the jaw or to treat conditions.
The devices of concern include:
- Anterior Growth Guidance Appliance (AGGA) and Fixed Anterior Growth Guidance Appliance (FAGGA),
- Anterior Remodeling Appliance (ARA) and Fixed Anterior Remodeling Appliance (FARA),
- Osseo-Restoration Appliance (ORA) and Fixed Osseo-Restoration Appliance (FORA), and
- Any other similar device types.
The FDA is aware of these devices being used to treat conditions such as obstructive sleep apnea and temporomandibular joint disorder of the jaw, and to remodel the jaw in adults. However, the safety and effectiveness of these devices intended for these uses have not been established, and these devices are not cleared or approved by the FDA.
The FDA is also aware of reports of serious complications with use of these devices. The FDA is asking patients, caregivers, and health care providers to report any complications with these devices to the FDA.
This safety communication provides:
- Recommendations for patients, caregivers, and health care providers.
- Background information on the issue.
- The FDA’s actions to address the issue.
- Instructions to report problems with devices to the FDA.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).
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