Carriere® Motion Pro® Clear Bite Corrector

The Carriere® Motion Pro® Clear Bite Corrector is a single-use, direct bond orthodontic appliance made of 17-4 stainless steel and polyethersulfone. It attaches a maxillary or mandibular canine or first premolar to the molar to provide orthodontic movement and tooth alignment for Class II and Class III malocclusions (symmetrical and asymmetrical) and Class I cases with mesially positioned molars or mandibular crowding. The appliance is for use by dental and orthodontic professionals on any patient demographic undergoing orthodontic treatment.

The subject device is substantially equivalent to predicate devices in design features, mode of use, principles of operation, manufacturing, packaging, labeling, and biocompatibility. The subject device and secondary predicate (K160720) are manufactured from polyethersulfone and 17-4 stainless steel, while the primary predicate uses 17-4 stainless steel only. Both the subject device and primary predicate include an optional drop-in hook made from 304 stainless steel, which is not present in the secondary predicate.

Not stated in this summary.

The device does not raise new questions of safety and effectiveness compared to the predicate devices. Mechanical testing evaluated bond strength, hook strength, connection strength, and clear bar rigidity, with results compared to both primary and secondary predicates. The minor differences between the proposed device and predicates do not raise new safety or effectiveness concerns, supporting substantial equivalence.