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    K Number
    K243370
    Device Name
    DentaTOOTH
    Manufacturer
    Asiga Pty Ltd
    Date Cleared
    2025-05-05

    (187 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Asiga Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Asiga DentaTOOTH is intended exclusively for professional dental work. Asiga DentaTOOTH is a 3D print resin indicated for the manufacturing of 3D printed temporary crowns, bridges, inlays, onlays and veneers.
    Device Description
    DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3. DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce denture temporary dental restorations. DentaTOOTH resin has been validated for use with the Asiga Max Series and Pro Series printers for the manufacture of temporary dental restorations at 385nm wavelengths. DentaTOOTH is a light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. DentaTOOTH is a Type 2, Class 2 resin per ISO 10477:2020 and Type 1, Class 2, Group 2 resin per ISO 4049:2019. DentaTOOTH has a shelf life of 36 months. The device may be stored in Asiga Max and Pro Series printers for up to 4 weeks with hood closed. DentaTOOTH is compliant to ISO 10477:2020 and ISO 4049:2019 for polymer based crown and veneering materials, and polymer based restorative materials, respectively.
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    K Number
    K243356
    Device Name
    Asiga DentaBASE
    Manufacturer
    Asiga Pty Ltd
    Date Cleared
    2025-04-11

    (164 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Asiga Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Asiga DentaBASE is intended exclusively for professional dental work. Asiga DentaBASE is a 3D print resin intended for the manufacturing of 3D printed denture bases. The denture bases produced are suitable for dental indications including removable dentures.
    Device Description
    Asiga DentaBASE resins are used with digital light processing (DLP) based 3D printers to produce denture bases. DentaBASE resin has been validated for use with the Asiga Max Series and Pro Series 3D printers. Asiga DentaBASE is a Type 4 light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. Asiga DentaBASE resin material is used in a DLP 3D printer, which prints the denture base from CAD data. The denture base is built by solidifying successive layers of photopolymer against each other. Each layer is light cured before adding the next layer, with post-curing in a light chamber unit. The 3D printer and light-curing unit are not included with the device. The device is supplied as a pre-mixed resin in one color, natural pink. The device is supplied non-sterile, and it not intended to be sterilized. Asiga DentaBASE has a shelf life of 36 months. AsigaDentaBASE is compliant to ISO 20795-1 for Type 4 materials. AsigaDentaBASE is a surface device with mucosal membrane contact for >30 days and is compliant to ISO 10993-1 and ISO 7405.
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