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510(k) Data Aggregation

    K Number
    K220894
    Device Name
    SmileGuard
    Manufacturer
    EnvisionTEC GmbH
    Date Cleared
    2022-06-10

    (74 days)

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

    EnvisionTEC GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SmileGuard™ light curable resin is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards and splints.
    Device Description
    The SmileGuard™ system combines the light-curable resin, for use with a scanner with design software, validated 3D printer and a curing unit. These components are used together during the additive manufacture of dental appliance splints/mouth guards. The light-curing resin is a proprietary composition of acrylate/methacrylate, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories and dental practices to make customized bite splints, using the 3D-printer. The resin is filled in lightproof 1 kg PE bottles labeled and offered together with a programmed RFID chip (referred to as TAG), which is required for use with the validated EnvisionTEC 3D printers. The TAG contains information identifying the resin: material, name and amount. The SmileGuard™ resin is an alternative material to heat-curing and auto-polymerizing resins.
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    K Number
    K211101
    Device Name
    E-Temp
    Manufacturer
    EnvisionTEC GmbH
    Date Cleared
    2021-06-14

    (62 days)

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

    EnvisionTEC GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    E-Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns and temporary bridges in dental laboratories. The material is an alternative to traditional restorative dental material. E-Temp is intended exclusively for professional dental work. Fabrication of dental applications with E-Temp requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer's data, a digital light processing (DLP) printer, and curing light equipment.
    Device Description
    The E-Temp system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized temporary crowns or bridges. The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories to make the customized temporary crowns and bridges for patients who need restoration of their natural teeth. E-Temp is available in six different colors. The resin is packaged in lightproof 1 kg PE bottles along with a programmed RFID chip (referred to as TAG), which is required for use with the validated 3D printers. The TAG contains information identifying the resin material, name and amount. E-Temp resin is an alternative material to heat-curable and auto-polymerizable resins. EnvisionTECs Perfactory® 3D-Printer DLP models designed and validated for use with the E-Temp light cured resin are: EnvisionOne cDLM, with LED, Micro series, with LED, Vida Series, with LED, P4K Series, with LED, D4K Series, with LED.
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    K Number
    K210977
    Device Name
    E-Dent 1000
    Manufacturer
    EnvisionTEC GmbH
    Date Cleared
    2021-05-25

    (54 days)

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

    EnvisionTEC GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    E-Dent 1000 is a light-curable resin indicated for the fabrication of: - individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area, - individual and fixed single veneers, - artificial teeth for dental prostheses, which are used for removable permanent full dentures, - individual and removable monolithic full and partial dentures in dental laboratories. The material is an alternative dental material. E-Dent 1000 is intended exclusively for professional dental work. Fabrications with E-Dent 1000 requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression, or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer's data, a digital light processing (DLP) printer, and curing light equipment.
    Device Description
    The E-Dent 1000 system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized E-Dent 1000 restorative dental products. The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories to make the customized temporary crowns and bridges for patients who need restoration of their natural teeth. E-Dent 1000 is available in six different colors. The resin is packaged in lightproof 1 kg PE bottles along with a programmed RFID chip (referred to as TAG), which is required for use with the validated 3D printers. The TAG contains information identifying the resin material, name and amount. E-Dent 1000 resin is an alternative material to heat-curable and auto-polymerizable resins. EnvisionTECs Perfactory® 3D-Printer DLP models designed and validated for use with the E-Dent 1000 light cured resin are: • EnvisionOne cDLM, with LED • Micro series, with LED • Vida Series, with LED • P4K Series, with LED • D4K Series, with LED
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    K Number
    K203641
    Device Name
    E-Denture Pro
    Manufacturer
    EnvisionTEC GmbH
    Date Cleared
    2021-03-30

    (106 days)

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

    EnvisionTEC GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    E-Denture Pro is a light-curable resin indicated for the fabrication of denture bases fabricated in dental laboratories for full removable dentures. The material is an alternative to traditional heat-curable and auto polymerizing resins. E-Denture Pro is intended exclusively for professional dental work. Fabrication of denture bases with E-Denture Pro requires a computer-aided and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.
    Device Description
    The E-Denture Pro system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized denture base for the removable full denture. The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories and dental practices to make the denture bases for removable full dentures. The resin is offered in lightproof 1 kg PE bottles along with a programmed chip (referred to as TAG), which is required for use with the 3D printer. The TAG contains information identifying the resin material, name and amount. E-Denture Pro resin is an alternative material to heat-curable and auto-polymerizable resins. EnvisionTECs Perfactory® 3D-Printer models designed and validated for use with the E-Denture Pro light cured resin are: EnvisionOne cDLM, with LED Vida Series, with LED P4K Series, with LED D4K Series, with LED
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    K Number
    K201173
    Device Name
    E-Guard
    Manufacturer
    EnvisionTEC GmbH
    Date Cleared
    2020-11-27

    (210 days)

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

    EnvisionTEC GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EnvisionTEC's E-Guard is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations, i.e. bite guards/splints and occlusal night guard/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
    Device Description
    The E-Guard system combines a scanner with design software, the light-cured resin, a 3D printer and a curing unit. These components are used together during the manufacture of the dental appliance splint/bite guard. The light-curing resin is composed of acrylate/methacrylate, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories and dental practices to make customized bite splints, using the 3D-printer. The resin is offered in lightproof 1 kg PE bottles along with a programmed chip (referred to as TAG), which is required for use with the 3D printer. The TAG contains information identifying the resin material, name and amount. The E-Guard resin is an alternative material to heat-cured and auto-polymerizing resins.
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