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Sureclear™ aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition.

OraMetrix sureclear™ aligners are orthodontic aligners fabricated from a clear, thin thermoformed plastic in a sequential series, individually customized for each patient based on a doctor's prescription to progressively reposition the teeth via gentle, corrective forces in the upper and lower dental arches. The patient's dentist or orthodontist will use a digital scanning system to capture the anatomy and locations of the patient's teeth, and then after evaluating those will fill out an electronic prescription form describing the treatment plan using OraMetrix's previously cleared Suresmile® System software (K002620). The digitally scanned tooth data and prescription form are sent electronically via the Suresmile System® to OraMetrix technicians, using the Suresmile® System, separate the tooth scan data into individual tooth models representing the patient's malocclusion. Additional OraMetrix technicians, also using the Suresmile® System's software, interpret the doctor's instructions provided on the prescription form; produce a setup and a sequence of intermediate models corresponding to each stage of the patient's aligner therapy. The setup and the intermediate stages are sent, via the Suresmile® System, back to the doctor for review, modification or approval. Once the doctor is satisfied with the planned therapy, an order for the production, packaging and shipment of the aligners is made via the Suresmile® System.