A single-patient, reusable, moulded intraoral device for use during orthodontic treatment. It is designed to retract lips and cheeks away from the dentition. The device is inserted into the patient’s mouth to retract soft tissue and maintain retraction while the intraoral images captured form part of the clinical information available to the orthodontist. It comes in two sizes: standard and small, consisting of a frame, an adjustable slider component, instructions for use and resealable pouch packaging. The components are packaged together for retail sale and are not intended to be sold separately. It is manufactured from ABS thermoplastic. The slider component allows temporary positioning of a smartphone camera. The device does not perform imaging itself and does not enhance smartphone functionality beyond positioning.

GIR 1 and 6 Note (II) of HSEN to Heading 9018 Note (II)(1) of HSEN to Heading 9018 Text to code 9018, 9018 49 & 901849 90, 9018499000.