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510(k) Data Aggregation

    K Number
    K251390
    Device Name
    MTA vpt
    Manufacturer
    VOCO GmbH
    Date Cleared
    2025-07-03

    (59 days)

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

    VOCO GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251239
    Device Name
    GrandioSO Unlimited
    Manufacturer
    VOCO GmbH
    Date Cleared
    2025-05-21

    (29 days)

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

    VOCO GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - class I to V restorations - reconstruction of traumatically damaged anteriors - facetting of discolored anteriors - correction of shape and shade for improved aesthetic appearance - locking, splinting of loose teeth - repairing veneers - restoration of deciduous teeth - core-build-up under crowns - composite inlays
    Device Description
    Not Found
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    K Number
    K231817
    Device Name
    AlignerFlow LC
    Manufacturer
    VOCO GmbH
    Date Cleared
    2023-12-01

    (163 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    VOCO GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Retention of aligners e.g. by fabrication of aligner attachments - Bonding of lingual retainers - Occlusal build-ups
    Device Description
    Not Found
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    K Number
    K231591
    Device Name
    V-Print c&b temp
    Manufacturer
    VOCO GmbH
    Date Cleared
    2023-07-31

    (60 days)

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

    VOCO GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temporary crowns and bridges
    Device Description
    Not Found
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    K Number
    K230877
    Device Name
    Admira Fusion 5
    Manufacturer
    VOCO GmbH
    Date Cleared
    2023-07-13

    (105 days)

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

    VOCO GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Class I to V restorations - Base in class I and II cavities - Reconstruction of traumatically damaged anteriors - Facetting of discoloured anteriors - Correction of shape and shade for improved aesthetic appearance - Locking, splinting of loose teeth - Repairing veneers, small enamel defects and temporary C&B-materials - Extended fissure sealing - Restoration of deciduous teeth - Core build-up - Composite inlays
    Device Description
    Not Found
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    K Number
    K220236
    Device Name
    V-Print dentbase
    Manufacturer
    Voco GmbH
    Date Cleared
    2022-09-21

    (237 days)

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

    Voco GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Removable denture bases
    Device Description
    Not Found
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    K Number
    K220640
    Device Name
    Bifix Hybrid Abutment Cement
    Manufacturer
    VOCO GmbH
    Date Cleared
    2022-08-23

    (172 days)

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

    VOCO GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent extraoral and intraoral luting of superstructures (incl. Mesostructures) made of metal, ceramics, zirconium dioxide and polymers (composite, hybrid ceramics or PMMA) on prefabricated adhesive/titanium bases (extraorally only), on customized titanium and zirconium dioxide bases (both extraorally and intraorally) as well as on dental hard tissue.
    Device Description
    Not Found
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    K Number
    K220743
    Device Name
    CediTEC
    Manufacturer
    VOCO GmbH
    Date Cleared
    2022-07-05

    (113 days)

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

    VOCO GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Luting of prefabricated prosthetic teeth and CAD/CAM-produced individual teeth and tooth sections in CAD/CAMproduced denture bases - Luting of prosthetic teeth in the scope of a repair or extension
    Device Description
    Not Found
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    K Number
    K213149
    Device Name
    VOCO Retraction Paste
    Manufacturer
    Voco GmbH
    Date Cleared
    2021-12-09

    (73 days)

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

    Voco GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For temporary retraction of the marginal gingiva to provide a dry gingival sulcus when the periodontium is healthy prior to, e.g - analogue or digital impressions - cementation of temporary and permanent restorations - preparation of class II and V fillings
    Device Description
    Not Found
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    K Number
    K201091
    Device Name
    V-Print splint
    Manufacturer
    VOCO GmbH
    Date Cleared
    2020-11-06

    (197 days)

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

    VOCO GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Therapeutic splints - Auxiliary parts and functional parts for diagnostics - Manufacturing of patient-matched night guards/splints
    Device Description
    Not Found
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