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510(k) Data Aggregation

    K Number
    K170207
    Device Name
    Obturys
    Manufacturer
    Itena Clinical
    Date Cleared
    2017-07-31

    (188 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Itena Clinical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K162960
    Device Name
    TotalC-Ram
    Manufacturer
    ITENA CLINICAL
    Date Cleared
    2017-03-14

    (141 days)

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

    ITENA CLINICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for the permanent cementation of ceramic (including zirconia), composite and metal-based posts, crowns, bridges, veneers, inlays and onlays.
    Device Description
    TotalC-Ram is permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement.
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    K Number
    K122551
    Device Name
    PROVITEMP
    Manufacturer
    ITENA CLINICAL
    Date Cleared
    2013-06-14

    (297 days)

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

    ITENA CLINICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K122521
    Device Name
    PREVENT SEAL
    Manufacturer
    ITENA CLINICAL
    Date Cleared
    2013-06-11

    (295 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITENA CLINICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prevent Seal is used by dental profesionnals primarily in young children : - . To fill and seal pit and fissure depressions (faults in the enamel) of teeth to prevent cavities : - . Covering layer or " initial layer " in the fabrication of esthetically demanding composite restorations ; and - . For repairs of composite restorations (in particular filling of voids, leveling out of porosities and minor chips).
    Device Description
    Prevent Seal is a fluoride releasing, white, light-cured acrylate resin. Not manufactured with Bisphenol A.
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    K Number
    K122549
    Device Name
    DENTO TEMP
    Manufacturer
    ITENA CLINICAL
    Date Cleared
    2013-04-26

    (248 days)

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

    ITENA CLINICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for: 1) quick temporary cementation of temporary crowns and bridges; 2) rebasing of crowns; and 3) permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired. DentoTemp is fully compatible with both acrylic and composite (bis-acryl) temporary materials and as a result, is indicated on both natural and metal implants abutments.
    Device Description
    DentoTemp is a dental long term acrylic-urethane polymer based temporary cement. It does not contain eugenol or zinc oxyde. It is a unique 2-stage polymerization composition which does not harm temporary crowns and does not interfere with permanent cements.
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    K Number
    K121804
    Device Name
    PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM
    Manufacturer
    ITENA CLINICAL
    Date Cleared
    2013-04-19

    (304 days)

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

    ITENA CLINICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TotalCem The device is intended for the cementation of posts, crowns, bridges, inlays and onlays. DentoCem The device is intended for permanent cementation of: - crowns and bridges, inlays, onlays, posts and cores, ceramic crowns, Maryland . bridges and veneers; - . implant prosthesis: - orthodontic attachments: - amalgam restorations: - veneering of alloys: and ● - composite restorations. .
    Device Description
    TotalCem: TotalCem is a permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement. DentoCem: DentoCem is a chemical-curing, multi-purpose, dual-cured (auto/photopolymerizable), radio opaque permanent adhesive resin cement comprised of two easy-to-mix components.
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    K Number
    K122522
    Device Name
    DENTOETCH QUICKBOND BOND ACTIVATOR
    Manufacturer
    ITENA CLINICAL
    Date Cleared
    2013-03-19

    (211 days)

    Product Code
    KLE, EBF
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITENA CLINICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DentoEtch: It is intended used for etching tooth enamel and dentine when preparing surfaces for application of composites. Quickbond: It is intended for: Bonding composite to enamel and/or dentin; Bonding veneers, crowns & bridges, onlays and inlays; Bonding composite core built-up material; Bonding of composite to metal, Intraoral repairs (i.e. composite, fractured crowns & bridges, inlays & onlays and veneers); Treatment of hypersensitive teeth or exposed root surfaces; and Cavity sealing under amalgam restorations Bond Activator: It is intended for use to enable the practitioner to use self-cure techniques for the indications where dual-cured adhesive may be desired.
    Device Description
    DentoEtch: DentoEtch is an etching gel phosphoric acid 37%. Quickbond: Simple to use, two-bottle, two step self-etching bonding system, with a first bottle containing the primer and a second one containing the bonding agent. This subject device may also be used with a self-curing activator
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    K Number
    K121769
    Device Name
    DENTOCORE / DENTOCORE BODY
    Manufacturer
    ITENA CLINICAL
    Date Cleared
    2013-03-05

    (263 days)

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

    ITENA CLINICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject devices are intended to serve for the fabrication of core build-ups. They are also intended to serve as a base cement to affix pins and posts. They may be used with any Bis-GMA compatible bonding agent.
    Device Description
    The subject devices are dual-cure (auto and photo), nanofilled resin composite materials. They are stackable for easy setting, with no condensation, radio opaque and fluoride releasing. The subject devices are presented in an Automix syringe and a Cartridge used with a gun. Dentocore and Dentocore Body have the same intended use; the former possessing a relatively higher viscosity. This quality is a selection for practitioners choosing this type of material. The subject devices present numerous advantages, notably the following: Good compressive strength, Low polymerization shrinkage, Fluorure release, Very high radio opacity properties.
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