d46e28cb-72b4-4618-8a69-4d6f6c1a46d5NewPublished12022-12-192022-12-09In Commercial DistributionD82864092500PrimaryHIBCCMolar Rotator6409250113352686FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC1falsetruefalsefalsefalsetruefalsefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse64769Orthodontic palate expander/teeth aligner, bondedAn orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism, positioned in the palate cavity with wires extending laterally, ending in bonded teeth-engaging bands. It is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to effect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.falseActiveDZCWire, Orthodonticfalsefalse