Device typeOrthodontic appliance positioning tray: A custom-made dental device in the form of a patient’s dentition with slots/sockets intended to position and hold in place a set of orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) [not included] to bond them to teeth during a single procedure; the orthodontic appliances are loaded onto the device by the orthodontist prior to the procedure. Also known as an indirect bonding tray, it is typically made of synthetic polymer materials and is manufactured from an oral cavity impression or oral scan for a specific patient. This is a single-use device.
FDA categoryIndirect Bonding Tray
Device ID90856379007118
Catalog numberDIGI-500128
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information