Dental Devices to Treat Sleep Apnea and TMD
The FDA is currently evaluating safety concerns related to certain dental devices called fixed (non-removable) palatal expanders, which are used on adults for jaw remodeling or to treat conditions like obstructive sleep apnea (OSA) and temporomandibular joint disorder (TMD).
About the devices
Fixed palatal expansion devices are used during orthodontic treatment to widen the roof of the mouth in children and adolescents whose upper jaw bones are not yet fused. However, in adults, the upper jaw bones are fused, making the use of fixed palatal expansion devices difficult and potentially harmful. Patients are advised to consult with their dental professional if they have any concerns about a dental device.
Types of devices
These devices include the Anterior Growth Guidance Appliance (AGGA), Fixed Anterior Growth Guidance Appliance (FAGGA), Anterior Remodeling Appliance (ARA), Fixed Anterior Remodeling Appliance (FARA), Osseo-Restoration Appliance (ORA), Fixed Osseo-Restoration Appliance (FORA), and any other similar device types. The safety and effectiveness of these devices have not been established, and they have not been cleared or approved by the FDA.
Serious complications
The FDA is also aware of reports of serious complications associated with the use of these devices, such as chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss. Patients, caregivers, and healthcare providers are urged to report any complications with these devices to the FDA to help identify and understand the risks associated with these devices.
FDA actions
The FDA is currently evaluating the safety concerns with certain dental devices, such as the AGGA, FAGGA, ARA, FARA, ORA, and FORA, that are used to treat conditions like OSA, TMD, and jaw remodeling in adults. These devices have not been approved or cleared by FDA, and their safety and effectiveness have not been established.
The agency is also identifying and contacting responsible entities to communicate their concerns about these devices. The agency plans to investigate potential violations and act as necessary. Patients, caregivers, and healthcare providers will be kept informed as new information becomes available.
Report dental-medical device concerns
Patients with problems or concerns regarding these dental devices are advised to consult with their dental professional as the use of these devices may result in serious complications requiring intervention.
Dental patients who have experienced issues with a dental apparatus are encouraged to file a voluntary report through MedWatch or contact their local FDA Consumer Complaint Coordinator to report concerns.
Safety notice
Read the complete FDA safety notice here.