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510(k) Data Aggregation

    K Number
    K232448
    Device Name
    FREEPRINT® splintmaster
    Manufacturer
    Detax GmbH
    Date Cleared
    2023-10-12

    (59 days)

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

    Detax GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FREEPRINT® splintmaster is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment. FREEPRINT® splintmaster is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, splints, and repositioners.
    Device Description
    The Subject device is a light-cured methacrylate-based resin used in 3D printers to produce dental mouthguards, nightguards, splints, and repositioners. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigment. The Subject device is used by a dental professional (dentist or dental technician) for the additive Computer-Aided Manufacturing (CAM) of dental mouthguards, nightguards, splints, and repositioners. There are two models of the Subject device which are referred to as FREEPRINT® splintmaster flex and FREEPRINT® splintmaster taff with slightly different material properties for either a more flexible or rigid final product. The Subject device resin is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are one-time use, prescription-only devices.
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    K Number
    K222877
    Device Name
    FREEPRINT crown
    Manufacturer
    DETAX GmbH
    Date Cleared
    2022-09-23

    (1 days)

    Product Code
    EBF, EBG
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    DETAX GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FREEPRINT® crown is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The FREEPRINT® crown material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
    Device Description
    The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of temporary or permanent dental restorations such as crowns and bridges, inlays, veneers and full crown restorations including occlusal surfaces. The Subject device is used by a dental technician for the CAD/CAM manufacturing of temporary dental restorations. Restorations fabricated using the Subject device are one-time use, prescription-only devices. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigments. Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties. The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
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    K Number
    K200461
    Device Name
    Freeprint denture
    Manufacturer
    Detax GmbH & Co. KG
    Date Cleared
    2020-11-16

    (265 days)

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

    Detax GmbH & Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FREEPRINT denture is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures. FREEPRINT denture is intended for continuous use in the oral environment, exclusively for professional dental work. FREEPRINT denture can be used in combination with a stereolithographic 3D printer using a 3D-printer is not part of the device.
    Device Description
    FREEPRINT denture is a light-cured one-component materials for the Digital Light Processing (DLP)-printing of denture base products. It is stored in 500 and 1000ml HDPE bottles. This Product is a liquid photo-curable material that is polymerized, by the photo-initiator contained in the resin. This device can be manufactured with 3D stereolithographic printer with 385nm wavelength light source. Curing in a 3D printer is related to the conditions of the printer equipment and is typically 100µm in thickness. FREEPRINT denture products are post cured with a xenon flashlight, in a nitrogen atmosphere.
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    K Number
    K200273
    Device Name
    FREEPRINT temp
    Manufacturer
    DETAX GmbH & Co.KG
    Date Cleared
    2020-10-27

    (266 days)

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

    DETAX GmbH & Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FREEPRINT temp is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.
    Device Description
    FREEPRINT temp is a family of light-cured-component materials for the Digital Light Processing (DLP)-printing of temporary Crowns & Bridges (C&B) material. It is stored in 500 and 1000ml HDPE bottles. It contains materials with colours of A1, A2, and A3 based on the shade guide. This Product is a liquid photo-curable material that is polymerized by UV laser at 385nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (385nm) by the photo-initiator contained in the resin. This device can be manufactured with 3D stereolithographic printer with 385nm wavelength lightsource. Curing in a 3D printer is related to the conditions of the printer equipment and is typically 50µm in thickness. Output resolution ranges from 34µm to 75µm on the x, y axis.
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    K Number
    K162654
    Device Name
    mollosil plus
    Manufacturer
    DETAX GmbH & Co.KG
    Date Cleared
    2017-03-13

    (171 days)

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

    DETAX GmbH & Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for fabricating long-term soft denture relinings by direct or indirect application.
    Device Description
    Not Found
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    K Number
    K100247
    Device Name
    DETAX IMPLANTLINK SEMI
    Manufacturer
    DETAX GMBH & CO. KG
    Date Cleared
    2010-07-23

    (177 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    DETAX GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DETAX implantlink® semi is designed for the temporary luting of implant-retained restorations. Requires no separating agents. Luted restorations can be removed. with standard devices (i.e. Crown Butler, Corona Fix).
    Device Description
    Not Found
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    K Number
    K994012
    Device Name
    TEMPOFIT, MODEL 02693
    Manufacturer
    DETAX GMBH & CO. KG
    Date Cleared
    2000-02-16

    (82 days)

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

    DETAX GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Material for making temporary crowns and bridges, self curing, fast setting, bis-acrylic-composite 2:1
    Device Description
    Not Found
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