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510(k) Data Aggregation

    K Number
    K123929
    Device Name
    BEGOPAL+
    Manufacturer
    BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
    Date Cleared
    2013-03-14

    (84 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Product Code :

    EJH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.
    Device Description
    BegoPal+ is a palladium containing cobalt-chromium alloy for fabrication of porcelain fused to metal dental restorations. BegoPal+ is available as powder and is processed by selective laser melting.
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    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?
    Product Code :

    EJH

    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.
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    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?
    Product Code :

    EJH

    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?
    Product Code :

    EJH

    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
    K033045
    Device Name
    DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
    Manufacturer
    AMERICAN GREEN DENT. MFG, INC.
    Date Cleared
    2003-12-23

    (85 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Product Code :

    EJH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "DREAMBOND" (Ceramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations. "DREAMCAST CHROME" (Partial Denture Dental Casting Alloy) is for the use in dental laboratories, suitable for preparation of removable dental applications. "DREAMCAST V" (Cramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations. "DREAM FLEXICAST"" (Partial Denture Cobalt Base Alloy") is for the use in dental laboratories. suitable for preparation of removable dental applications. "DREAM LITHECAST" (Ceramic dental casting Alloy Nickel & Beryllium Free) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.
    Device Description
    General:- Dental Alloys Specific :- "DREAMBOND""DREAMCAST CHROME" "DREAMCAST V" "DREAM FLEXICAST" "DREAM LITHECAST"
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    K Number
    K032136
    Device Name
    WIROBOND C
    Manufacturer
    BEGO U.S.A.
    Date Cleared
    2003-09-04

    (55 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Product Code :

    EJH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wirobond C is a non-Precious dental casting alloy to make full crowns and copings for porcelain fused to metal dental restorations.
    Device Description
    Wirobond C is a non-Precious dental casting alloy.
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    K Number
    K031627
    Device Name
    NANO-TICROWN
    Manufacturer
    NANO-WRITE CORP.
    Date Cleared
    2003-06-11

    (15 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Product Code :

    EJH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device entitled: Nano-TiCrown ™ Titanium Metal Alloy Dental Device (aka: Nano-TiCrown ™ ) is a Titanium/Titanium Nitride based alloy intended for use as a base metal alloy in the making of single unit device porcelain-fused-to-metal (PFM) prosthetic dental materials and custom-made dental prosthetic devices, such as a porcelain-to-metal veneer for a tooth. The Nano-TiCrown ™ is intended to be used as a single unit coping device, i.e., a PFM dental restorative device is not intended for use on metal only or other non-ceramic porcelain restorations. Nano-TiCrown ™ is a Class II (non-exempt) medical device that is described within the Dental Products medical specialty panel of the U.S. Food and Drug Administration (FDA), under FDA Regulation Number 21 CFR 872.3710, and Product Code: EJH. The Nano-TiCrown ™ device is recommended for all anterior and posterior tooth dental crown restorations. This Titanium Nitride coping device (i.e., Nano-TiCrown ™) is to be used by dental laboratories in the fabrication of PFM dental crowns for dentists, This Nano-TiCrown ™ is intended to be marketed to medical professionals and for point-of-care use, and is not intended for sale over-the-counter in its current design. [Warning: This device should be used with caution where the patient has known metal allergies and specifically is not intended to be used where known patient allergies to Titanium exist].
    Device Description
    The Nano-TiCrown ™ Titanium Nitride dental coping substructure for full fused porcelain to metal PFM devices, consists of a Titanium Nitride substructure. The Nano-TiCrown ™ device is intended to be used in single unit coping dental restorative devices with full porcelain to metal coverage for PFM devices.
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    K Number
    K030632
    Device Name
    PD CASTA-H
    Manufacturer
    MOUNTAIN MEDICO, INC.
    Date Cleared
    2003-05-07

    (68 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Product Code :

    EJH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-Precious Dental Casting Alloy . Suitable for use in fabrication of removable dental appliances.
    Device Description
    Not Found
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    K Number
    K030416
    Device Name
    CERACAST-V
    Manufacturer
    MOUNTAIN MEDICO, INC.
    Date Cleared
    2003-04-14

    (63 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Product Code :

    EJH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-Precious Dental Casting Alloy. Suitable for use in the fabrication of Ceramic Fused to Metal (metallo-ceramic) dental restorations.
    Device Description
    Not Found
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    K Number
    K030161
    Device Name
    SUPERBOND
    Manufacturer
    AMERICAN DENT-ALL, INC.
    Date Cleared
    2003-03-17

    (60 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Product Code :

    EJH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Superbond (Ceramic Dental Casting Alloy) is for the use in Dental Laboratories, suitable for use in fabrication of metal-ceramic dental restoration.
    Device Description
    Not Found
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