0d9d8cff-17a5-409a-8d1e-8fd1d25d1472NewPublished12026-05-152026-05-07In Commercial DistributionD775AASS0PrimaryHIBCCSuper Spring AlignerAASS041854332Great Lakes Dental Technologies, Ltd.1truefalsefalsefalsefalsefalsetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK17276500044738Orthodontic progressive alignerA custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.falseActiveNXCAligner, Sequentialfalsefalse