Invisalign System

The Invisalign System is a removable orthodontic appliance consisting of a series of customized clear plastic aligners and 3D treatment planning software. It gently moves patients' teeth in small increments to correct malocclusion in patients with primary, mixed, or permanent dentition. An optional mandibular advancement feature addresses skeletal malocclusion, and a new optional integrated button allows attachment of orthodontic accessories like elastics.

The subject device adds an optional integrated button feature to aligners, which is similar to the predicate device's precision cut feature. This button allows doctors to attach orthodontic accessories such as elastics during treatment. The 3D treatment planning software visualizes button placement on aligners. The doctor still approves the treatment plan prior to manufacturing, maintaining the same workflow as the predicate.

Not stated in this summary.

The device has the same intended use and indications as the predicate (K241412). The integrated button feature is functionally equivalent to the predicate's precision cut feature—both enable attachment of orthodontic accessories. Complete functional and performance testing including durability, shear bond, retention, and biocompatibility all passed acceptance criteria and demonstrated the modification does not affect safety or effectiveness. The mechanism of action for treating malocclusion remains unchanged.