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510(k) Data Aggregation

    K Number
    K231775
    Device Name
    GR Resin System MSI
    Manufacturer
    Pro3dure Medical
    Date Cleared
    2024-08-08

    (419 days)

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

    Pro3dure Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The printodent® GR-10 guide | MSI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints. The printodent® GR-19.1 OA is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, splints, repositioners and retainers. The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
    Device Description
    The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers. GR-10 guide MSI is made of functional methacrylic resins and inorganic fillers and the GR-19.1 OA, and GR-19.1 OA MSI consist of functional (meth)acrylic resins, initiators, dyes, stabilisers and lactam. The GR-10 guide MSI, and GR-19.1 OA MSI are available in ocean blue shade, and the GR-19.1 OA is available in clear transparent. The resin is a liquid photo-curable material that is polymerized by image projection systems at ≤ 405 nm to create dental appliances. The GR Resin System MSI is intended to be used in conjunction with an additive Computer-Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems
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    K Number
    K212017
    Device Name
    Thermeo System
    Manufacturer
    Pro3dure Medical GmbH
    Date Cleared
    2022-04-08

    (284 days)

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

    Pro3dure Medical GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Thermeo powder / Thermeo liquid is a heat cured, moldable, acrylic compound system for use in the fabrication of dental appliances such as mouthguards, bruxism and TMJ splint appliances, and bite splints. The Thermeo blank is a disc intended for the fabrication of dental appliances such as mouthguards, buxism and TMJ splint appliances, and bite splints using CAD/CAM milling machines.
    Device Description
    The Thermeo powder/Thermeo liquid is a two-compound mixable device, containing a powder component and a liquid component. The device is heat cured for the fabrication of dental appliances. The Thermeo blanks are pre-made by pro3dure using the two-part mixable device. The Thermeo blank is intended to be used in conjunction with CAD/CAM milling technology systems.
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    K Number
    K211415
    Device Name
    GR Splint Resin System
    Manufacturer
    Pro3dure Medical GmbH
    Date Cleared
    2021-10-21

    (168 days)

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

    Pro3dure Medical GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GR Splint Resin System is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment: The GR-10 guide is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints. The GR-19 OA is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, repositioners and retainers. The GR-22 flex is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, and repositioners.
    Device Description
    GR Splint Resin System includes the GR-10 Guide Resin, GR-19 OA Resin, and GR-22 flex Resin. The GR Splint Resin System is made of functional methacrylic resins and inorganic fillers. The GR-10 Guide Resin, GR-19 OA Resin, GR-22 flex Resin It is available in light blue-transparent, clear transparent and rose-transparent shades. The resin is a liquid photo-curable material that is polymerized by image projection systems at 385 nm and 405 nm to create dental appliances. The GR-10 Guide Resin, GR-19 OA Resin, GR-22 flex Resin are intended to be used in conjunction with an additive Computer-Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems.
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    K Number
    K210298
    Device Name
    GR-14 Resin System
    Manufacturer
    Pro3dure Medical GmbH
    Date Cleared
    2021-05-05

    (91 days)

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

    Pro3dure Medical GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GR-14.1 denture is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.1 denture is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates. The GR-14.2 denture HI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.2 denture HI is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
    Device Description
    GR-14 Resin System includes the GR-14.1 denture and GR-14.2 denture HI and is made of functional methacrylic resins and inorganic fillers. It is available in three shades based on the shade guide, orange-pink, light-pink and deep-pink. The resin is a liquid photo-curable material that is polymerized by image projection systems at 405nm to create denture baseplates. The GR-14 Resin System is intended to be used in conjunction with an additive Computer- Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems. Preformed teeth are fixed into the denture base by extra gluing process with appropriate glue material.
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    K Number
    K201827
    Device Name
    GR-17 Resin System
    Manufacturer
    Pro3dure Medical GmbH
    Date Cleared
    2020-11-05

    (126 days)

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

    Pro3dure Medical GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GR-17 Resin System is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment. The GR-17 temporary is indicated for the fabrication, by additive manufacturing, of temporary anterior dental restorations. The GR-17.1 temporary is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and for the fabrication, by additive manufacturing, of preformed denture teeth to be used in a denture.
    Device Description
    GR-17 Resin System includes the GR-17 temporary and GR-17.1 temporary It and is made of functional methacrylic resins and inorganic fillers with particle sizes from 0.4 to 3 microns. It is available in seven shades based on the shade guide, A1, A2, A3, A3.5, B1, B2 and bleach. The resin is a liquid photo-curable material that is polymerized by image projection systems at 405nm to create temporary dental restorations, and preformed denture teeth to be used in a denture. The GR-17 Resin System is intended to be used in conjunction with an additive Computer-Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems.
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