Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K222418
    Device Name
    Nuvola
    Manufacturer
    Gruppo Europeo Ortodonzia srl
    Date Cleared
    2022-10-07

    (58 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gruppo Europeo Ortodonzia srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nuvola® aligner is intended for the orthodontic treatment of malocclusion.
    Device Description
    The Nuvola® device is a doctor-prescribed series of removable plastic aligners intended as an alternative to conventional wire and bracket technology. The Nuvola® gently moves teeth in small increments from their original state to a final, treated state for improved dental alignment. The system is used in patients with primary, mixed, and permanent dentition. The system consists of a series of doctor prescribed and customized plastic aligners (thermoformed PET-G sheeting material) that gently move the patient's teeth in rements from their original state to a more optimal, treated state to address malocclusion. The first device of the treatment matches the patient's dentition in its current state and then each subsequent aligner stage of the dentition shifted gradually toward the final desired position.
    Ask a Question

    Page 1 of 1