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The Invisalign® Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed, or permanent dentition and during orthodontic or orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.

The Invisalign® Palatal Expander (IPE) System (subject device) consists of a series of doctor prescribed, additive manufactured (3D Printed), removable orthodontic appliances (Invisalign® Palatal Expanders and Invisalign® Palatal Holders), and proprietary Align internal personnel facing shape operating 3D Orthodontic Software. The IPE System is indicated for the orthodontic treatment of malocclusion. The System is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed (primary and permanent), or permanent dentition during orthodontic or orthopedic treatment in children or adolescents. In adults, the IPE System is to be used in conjunction with surgery or other interventions when necessary. The proprietary 3D Orthodontic Software creates digital files for IPE System to be manufactured using digital data from the doctor/dental practitioner's prescription and patient scans. This submission adds an optional engagement feature to the existing Invisalign Palatal Expander System. Engagement features support the usage of commercially available orthodontic accessories such as elastics per the doctor's treatment plan for the treatment of malocclusion.

This submission adds an optional engagement feature to the existing Invisalign® Palatal Expander System (K232887). The proposed addition of engagement feature to the System is similar to the reference device, Invisalign System (K252380). Engagement features are designed to provide an anchor point to support the usage of commercially available orthodontic accessories such as elastics per the doctor's treatment plan for the treatment of malocclusion without altering the principle of operation of the device. The engagement features can be either forward facing or backward facing per the doctor's treatment plan. The IPE System with engagement features are additive manufactured using the same material as the predicate device (proprietary thermoplastic polyamide) and use the same manufacturing process as the predicate device.

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