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ClearForm Aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusions. The aligners position teeth by way of continuous gentle forces.

ClearForm Aligners consist of a series of customized removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force. A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop an orthodontic treatment plan. Using the software dental technicians produce a series of intermediate digital models corresponding to each stage of treatment, gradually aligning the patient's teeth according to the dental health professional's prescriptions. The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470. The prescribing doctor reviews and approves the treatment plan before the models/molds are produced. Once approved, physical models are produced from the digital model files. The aligner trays are formed over the physical models by using thermal forming equipment and a thermoplastic sheet. The aligner trays are sent to the dental health professional who then delivers them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the dental health professional to gradually move the teeth to the desired position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.