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510(k) Data Aggregation

    K Number
    K040180
    Device Name
    CONTINUM V
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    2004-03-04

    (37 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALBA DENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.
    Device Description
    This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.
    Ask a Question
    K Number
    K040179
    Device Name
    CONTINUM
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    2004-03-03

    (36 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALBA DENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crown and bridge dental restorations.
    Device Description
    This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy.
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    K Number
    K033356
    Device Name
    VERASOFT ES
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    2003-12-30

    (101 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALBA DENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy for use in the construction of cast crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872, the classification name for this device is Base Metal Alloy, a Class II device.
    Device Description
    This device is a non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy.
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    K Number
    K982094
    Device Name
    VERABOND 2
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1998-07-22

    (37 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALBA DENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.
    Device Description
    nonprecious, nickel-chromium-molybdenum based ceramic casting alloy
    Ask a Question
    K Number
    K972971
    Device Name
    NPG + 2
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1998-01-05

    (147 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALBA DENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a nonprecious, copper-aluminum (plus gold) based casting alloy for use in the construction of cast dental crown and bridge prosthetic devices, such as fullmetal-coverage (FMC) crowns and bridgework, inlays/onlays, posts and cores, and metal sub-structures for polymer crown and bridge resins.
    Device Description
    nonprecious, copper-aluminum (plus gold) based casting alloy
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    K Number
    K973265
    Device Name
    VERABOND 2V
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1997-10-16

    (48 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALBA DENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.
    Device Description
    This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.
    Ask a Question
    K Number
    K972607
    Device Name
    PLATALLOY
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1997-10-10

    (91 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALBA DENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a "white" colored, casting alloy for use in the construction of dental inlay and onlay prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.
    Device Description
    This device is a "white" colored, casting alloy for use in the construction of dental inlay and onlay prosthetic devices.
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    K Number
    K972533
    Device Name
    VERA SOLDER
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1997-09-05

    (60 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALBA DENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a "white" colored, soldering (welding) alloy for use in the construction and repair of crown and bridge dental prosthetic devices. According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.
    Device Description
    "White" Colored, Soldering (Welding) Alloy
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    K Number
    K972534
    Device Name
    ALFALLOY
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1997-09-05

    (60 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALBA DENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a "white" colored, casting alloy for use in full coverage and onlay prosthetic devices.
    Device Description
    "white" colored, casting alloy
    Ask a Question
    K Number
    K972118
    Device Name
    VERA PDN
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1997-08-15

    (71 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALBA DENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VERA PDN, a cobalt-chromium based alloy in nugget form, is intended for use in the fabrication of custom-made removable denture appliances.
    Device Description
    VERA PDN, a cobalt-chromium based alloy in nugget form
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