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510(k) Data Aggregation

    K Number
    K131753
    Device Name
    MERIDIAN
    Manufacturer
    AB ARDENT
    Date Cleared
    2013-11-14

    (153 days)

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

    AB ARDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Meridian is a direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth.
    Device Description
    Meridian is a light curing universal dental composite material of the latest nanohybrid type having an optimized chemical composition.
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    K Number
    K040465
    Device Name
    LATIT FLOW
    Manufacturer
    AB ARDENT
    Date Cleared
    2004-07-20

    (148 days)

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

    AB ARDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LATIT FLOW is to be used as a filling material for restoring function to teeth that have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Small posterior restorations, Class I. Mini cavities, minimal invasion dentistry Veneering of discolored anterior teeth Splinting of mobile teeth. Preventive restorations in molars and premolars. Repair of composite and ceramic veneers. Luting of porcelain and composite veneers As first layer of Class I or II restorations Contra indications: The placement of LATIT FLOW is contraindicated If a dry working field cannot be established or if the stipulated technique cannot be applied. If the patient is known to be allergic to the components of LATIT FLOW.
    Device Description
    Not Found
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    K Number
    K022971
    Device Name
    MICROHYBRID 11
    Manufacturer
    AB ARDENT
    Date Cleared
    2002-11-25

    (80 days)

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

    AB ARDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MICROHYBRID 11 is to be used as a filling material for restoring function to teeth that have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Posterior restorations, Class I, II. Splinting of mobile teeth. Preventive restorations in molars and premolars. Repair of composite and ceramic veneers. Inlays/onlays with extra-oral post tempering
    Device Description
    Not Found
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    K Number
    K022972
    Device Name
    MICROFILL 13
    Manufacturer
    AB ARDENT
    Date Cleared
    2002-11-22

    (77 days)

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

    AB ARDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MICROFILL 13 is to be used as a filling material for restoring function to teeth that have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV and V Corrections of anomalies such as peg shaped teeth Splinting of mobile anterior teeth. Repair of resin and ceramic veneers. Reconstruction of anterior trauma cases Veneering of discolored anterior teeth
    Device Description
    Not Found
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    K Number
    K022973
    Device Name
    ADHESIVE 14
    Manufacturer
    AB ARDENT
    Date Cleared
    2002-11-22

    (77 days)

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

    AB ARDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ADHESIVE 14 is to be used as a bonding agent for light curing composites and compomers to dentine tooth structure.
    Device Description
    Not Found
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    K Number
    K022974
    Device Name
    MICROHYBRID 12
    Manufacturer
    AB ARDENT
    Date Cleared
    2002-11-22

    (77 days)

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

    AB ARDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MICRCHYBRID 12 is to be used as a filling material for restoring function to teeth which have lost portions due to caries: IDirect, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Posterior restorations, Class I, II. Splinting of mobile teeth. Preventive restorations in molars and premolars. Repair of composite and ceramic veneers. Inlavs/onlays with extra-oral post tempering
    Device Description
    Not Found
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    K Number
    K022975
    Device Name
    ETCHING 15
    Manufacturer
    AB ARDENT
    Date Cleared
    2002-11-22

    (77 days)

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

    AB ARDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    E.TCHING 15 is used in the enamel or total etch techniques for Composite restorations Adhesive cementation of inlays (composite and ceramic)crowns, bridges, eneers, adhesive bridges and root posts. Splints Bonding of orthodontic attachments Fissure sealings
    Device Description
    Not Found
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    K Number
    K020452
    Device Name
    HIGH SILVER CONVENTIONAL
    Manufacturer
    AB ARDENT
    Date Cleared
    2002-05-07

    (85 days)

    Product Code
    EJJ
    Regulation Number
    872.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    AB ARDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HIGH SILVER CONVENTIONAL is to be used as a filling material for restoring function to teeth which have lost portions to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Single surface cavities such as Class I Two surface cavities such as MO, DO, FO, LO Three surface cavities such as MOD, FOD. Pinned onlays and half crowns. Core build-ups for cast half and full crowns. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
    Device Description
    HIGH SILVER CONVENTIONAL
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    K Number
    K011801
    Device Name
    FUTURA TOPCAP NON GAMMA-2
    Manufacturer
    AB ARDENT
    Date Cleared
    2001-08-16

    (69 days)

    Product Code
    EJJ
    Regulation Number
    872.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    AB ARDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FUTURA TOPCAP non gamma-2 is to be used as a filling material for restoring function to teeth which have lost portions to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Single surface cavities such as Class I Two surface cavities such as MO, DO, FO, LO Three surface cavities such as MOD, FOD. Pinned onlays and half crowns. Core build-ups for cast half and full crowns. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Labels will bear this caution.
    Device Description
    Not Found
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    K Number
    K991974
    Device Name
    FUTURA GLASS IONOMER SILVER REINFORCED
    Manufacturer
    AB ARDENT
    Date Cleared
    1999-09-17

    (98 days)

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

    AB ARDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE is to be used as a base, lining and filling material for restoring function to teeth which have lost portions to caries: - Class I and II cavities in deciduous teeth. - Repair of amalgam restored teeth (fractured restoration or tooth). - Class I and II cavities in selected permanent teeth. - Lining under amalgam or posterior composite restorations. - Cavities where radiopacity is a prime requirement. - Core build up material under crowns. - On root surface for locating overdentures. - Long term temporary replacement of cusps - Repairs to crown margins.
    Device Description
    Not Found
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