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510(k) Data Aggregation

    K Number
    K062065
    Device Name
    RIVA LUTING PLUS
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2006-11-15

    (118 days)

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

    SOUTHERN DENTAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Cementation of metal free or porcelain fused to metal inlays, onlays, bridges and crowns. - Cementation of stainless steel crowns. - Cementation of posts and screws. - Attachment of metal orthodontic bands. - Base or liner.
    Device Description
    Not Found
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    K Number
    K062064
    Device Name
    RIVA BOND LC
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2006-11-09

    (112 days)

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

    SOUTHERN DENTAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - · For direct bonding of composite resin to dentin and enamel. - · For direct bonding of composite resin to dentin and enamel in the co-cured technique. - · For direct bonding of composite resin to GI self cure or GI light cure base base base on and enamel in the "sandwich" technique. - · For · sealing to hypersensitive cervical areas and root surfaces of teeth.
    Device Description
    Not Found
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    K Number
    K050871
    Device Name
    RIVA PROTECT
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2005-06-10

    (65 days)

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

    SOUTHERN DENTAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pit and fissure sealing. Root/tooth surface protection and hypersensitivity prevention. Temporary restorations in non load-bearing applications, temporary endodontic sealing.
    Device Description
    Not Found
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    K Number
    K050870
    Device Name
    RIVA LIGHT CURE
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2005-06-03

    (58 days)

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

    SOUTHERN DENTAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Minimal Class I, II and III restorations. Class V restorations, deciduous teeth and geriatric restorations, core build-ups, root surface restorations, used as a base or liner, pit and fissure sealant, semi-permanent fillings.
    Device Description
    Not Found
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    K Number
    K050331
    Device Name
    ADHESIVE 1
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2005-03-24

    (42 days)

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

    SOUTHERN DENTAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Direct bonding of light-cured composite and compomer materials, dentin sealing, direct bonding of light-cured composite to ceramics, composite, metals and amalgam.
    Device Description
    Not Found
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    K Number
    K042452
    Device Name
    RIVA SILVER
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2004-12-07

    (88 days)

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

    SOUTHERN DENTAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Minimal Class 1 & 2 restorations, deciduous teeth restorations, core build-ups, restorations where opacity is desirable, root surface restorations, Class 5 restorations in nonaesthetic situations, base material for composite restorations, pit and fissure sealant, and semi-permanent fillings.
    Device Description
    Not Found
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    K Number
    K040393
    Device Name
    RIVA LUTING
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2004-04-30

    (73 days)

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

    SOUTHERN DENTAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Suitable for cementation of crowns, bridges, inlays and orthodontic bands. Also suitable for sealing interface between restoration and tooth and base / liner in deep restorations.
    Device Description
    Not Found
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    K Number
    K032152
    Device Name
    BENCO ADMIX
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2003-08-06

    (70 days)

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

    SOUTHERN DENTAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silver based alloy dental restorative used in all classes of restorations.
    Device Description
    Not Found
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    K Number
    K031658
    Device Name
    BENCO SPHERICAL
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2003-07-29

    (62 days)

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

    SOUTHERN DENTAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silver based alloy dental restorative used in all classes of restorations.
    Device Description
    Not Found
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    K Number
    K030568
    Device Name
    RADII
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2003-04-24

    (59 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUTHERN DENTAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polymerization of light curing dental materials with photo initiator for the wavelength range 440 – 480 nm. Suitable for light curing composite restorative materials, anterior composites, posterior composites, bonding agents, pit and fissure sealants, orthodontic adhesive and flowable composites.
    Device Description
    Not Found
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