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510(k) Data Aggregation

    K Number
    K222741
    Device Name
    DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
    Manufacturer
    HDI, Inc.
    Date Cleared
    2022-11-07

    (59 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    HDI, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast) - Crown and bridge impression - Inlay and onlay impression - Denture impression - Model impression DENU Putty Set(Regular, Fast) - Crown and bridge impression - Inlay and onlay impression
    Device Description
    The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use. Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices.
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    K Number
    K213339
    Device Name
    DENU Composite Resin, DENU Flow Resin
    Manufacturer
    HDI, Inc.
    Date Cleared
    2022-09-23

    (351 days)

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

    HDI, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DENU Composite Resin is indications for use in: - Direct anterior and posterior restorations - Core buildup - Splinting - Indirect anterior and posterior restorations including inlays, onlays and veneers DENU Flow Resin is indications for use in: - Class III restorations - Class V restorations - Small Class I restorations (non stress-bearing restorations) - Pit and fissure sealing in molars and premolars - Repair of small defects in esthetic indirect inlays - Base/liner under direct restorations
    Device Description
    DENU Composite Resin is light-cured composite resin which can be used in anterior and posterior teeth. This is classified into type 1, class 2, group 1 according to 4, ISO 4049:2019. DENU Flow Resin is light-cured flowable composite resin which can be used in anterior and posterior teeth. This is classified into type 1, class 2 group 1 according to 4, ISO 4049:2019.
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