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510(k) Data Aggregation

    K Number
    K210940
    Device Name
    LuxaPrint Ortho Plus
    Manufacturer
    DMG Digital Enterprises SE
    Date Cleared
    2021-09-03

    (158 days)

    Product Code
    MQC, EBI
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMG Digital Enterprises SE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabrication of orthodontic and dental appliances such as mouthguards, splints and positioners. The product is for use with DLP / SLA printers that work at wavelengths of 385 nm or 405 nm.
    Device Description
    LuxaPrint Ortho Plus is a (meth)acrylate-based photocurable polymer resin indicated for use for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and positioners, using a 3D printing process. LuxaPrint Ortho Plus material is used in a dental laboratory to fabricate a removable custom dental appliance. LuxaPrint Ortho Plus will be available in two variants matched to the operating wavelength of the 3D printer (385 nm and 405 nm). LuxaPrint Ortho Plus is used in conjunction with a compatible dental scanner, 3D printer, and curing equipment. Typical medical indications include bruxism and teeth grinding, or stabilization of the tooth's position after active orthodontic treatment.
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