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510(k) Data Aggregation

    K Number
    K243720
    Device Name
    3Delta UNlimited
    Manufacturer
    DeltaMed GmbH
    Date Cleared
    2024-12-18

    (15 days)

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

    DeltaMed GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3Delta UNlimited is a light-curing dental resin for restoring or improving chewing function by prosthetically - reconstructing damaged or missing teeth using additively fabricated - permanent full crowns, veneers, inlays, onlays - temporary crowns & bridges (max. two consecutive pontics) - monolithic full and partial dentures - artificial denture teeth
    Device Description
    3Delta UNlimited is a light-curing dental resin.
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    K Number
    K230341
    Device Name
    ACRIFIX
    Manufacturer
    DeltaMed GmbH
    Date Cleared
    2023-04-06

    (57 days)

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

    DeltaMed GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Repair of removable partial and full dentures
    Device Description
    Not Found
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    K Number
    K212541
    Device Name
    3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix
    Manufacturer
    DeltaMed GmbH
    Date Cleared
    2022-01-10

    (151 days)

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

    DeltaMed GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Production of dentures. - 3Delta Denture Base: Light curing resin for additive manufacturing of denture bases - 3Delta Denture Bond: Light curing bonding agent for denture teeth and denture bases - 3Delta Denture Fix: Dual curing cementation composite for denture teeth and denture bases
    Device Description
    Not Found
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    K Number
    K211804
    Device Name
    3Delta Crown
    Manufacturer
    DeltaMed GmbH
    Date Cleared
    2021-12-06

    (178 days)

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

    DeltaMed GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Additive production of permanent anterior and posterior restorations, e.g. - Single-tooth crowns - Veneers, inlays, onlays
    Device Description
    Not Found
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    K Number
    K200039
    Device Name
    P pro Crown & Bridge
    Manufacturer
    DeltaMed GmbH
    Date Cleared
    2020-07-31

    (205 days)

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

    DeltaMed GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Additive production of temporary anterior and posterior restorations, e.g. - Single tooth crowns. - Bridges (max. six units, max. two consecutive pontics). - Veneers, Inlays, Onlays.
    Device Description
    P pro Crown & Bridge is a flowable, light-curing, acrylate-based composite material for the additive production of temporary anterior and posterior restorations. It consists of multifunctional acrylic resins and fillers made of inorganic fillers ranging in size from 0.04 - 0.2 um. The raw materials used in the preparation have been used for many years in dental products. Exposition: The temporary crown and bridge resin has an intended gingival, enamel/dentine contact for more than 30 days.
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    K Number
    K102776
    Device Name
    EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM
    Manufacturer
    DELTAMED GMBH
    Date Cleared
    2011-02-18

    (147 days)

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

    DELTAMED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    e-DENT TEMPORARY resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment.
    Device Description
    e-DENT TEMPORARY RESIN is a radiopaque, filled, resin-based temporary dental restorative composite. In general terms, the device is a typical, high quality, esthetic dental composite, composed of difunctional acrylic monomers and silaceous fillers. The product will polymerize on exposure to high-intensity incandescent illumination, yielding a hard, esthetic, temporary restoration that mimics natural tooth structure. e-DENT TEMPORARY RESIN is intended to be fabricated in a laboratory-based, additive, Computer-Aided Manufacturing (CAM) and curing system, such as the EXTRA-ORAL CURING SYSTEM disclosed in this submission. The curing system consists of two pieces of equipment used to manufacture photocurable dental resin devices in a dental laboratory, using accompanying software to form and cure the devices.
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