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510(k) Data Aggregation

    K Number
    K110171
    Device Name
    NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
    Manufacturer
    NOBEL BIOCARE USA LLC
    Date Cleared
    2011-06-15

    (146 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOBEL BIOCARE USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NobelProcera Zi Abutments Thommen Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.
    Device Description
    Nobel Biocare's NobelProcera Zi Abutment Thommen Platforms is an endosseous dental implant abutment. The abutment attaches directly to Thommen dental implants and provides a platform for restoration. Nobel Biocare's NobelProcera Zi Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Zi Abutments are made entirely of zirconium oxide. The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.
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    K Number
    K073142
    Device Name
    NOBELREPLACE HEXAGONAL IMPLANT
    Manufacturer
    NOBEL BIOCARE USA LLC
    Date Cleared
    2008-01-11

    (65 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOBEL BIOCARE USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nobel Biocare's NobelReplace Hexagonal Implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
    Device Description
    NobelReplace Hexagonal Implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. The NobelReplace Hexagonal Implants are similar in design to the implants cleared under NobelReplace Tapered Conical Connection, K062566. The predicate internal square was changed to internal bexagonal connection.
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    K Number
    K062566
    Device Name
    NOBELREPLACE TAPERED CONICAL CONNECTION
    Manufacturer
    NOBEL BIOCARE USA LLC
    Date Cleared
    2006-12-06

    (97 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOBEL BIOCARE USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nobel Biocare's NobelReplace Tapered Conical Connection implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace Tapered Conical Connection implants are indicated for single or multiple unit restorations. The NobelReplace Tapered Conical Connection implants can be used in splinted or nonsplinted applications. The NobelReplace Tapered Conical Connection implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
    Device Description
    Nobel Biocare's NobelReplace Tapered Conical Connection implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. The NobelReplace Tapered Conical Connection implants are similar in design to the NobelReplace Tapered implants cleared under "Groovy Implants" (K050258). Like the NobelReplace Tapered implant, the NobelReplace Tapered Conical Connection implant is machined from commercially pure titanium, grade 4, have a tapered body contour, grooves on the collar, grooves on the threads of the body, and a TiUnite surface treatment. The difference between the two implants is that the NobelReplace Tapered Conical Connection implants have the same internal connection as the SFB implants, cleared under "SFB & CFB Implants"(K061003). The internal conical connection allows for the use of SFB abutments.
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    K Number
    K052885
    Device Name
    ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315
    Manufacturer
    NOBEL BIOCARE USA LLC
    Date Cleared
    2005-12-23

    (71 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOBEL BIOCARE USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic component directly The Zygonia Angled Abdamont is intended for use as an aid in prosthetic rehabilitation. The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prostherity in The Nobel Blocare Zygoma Angled Koathent is intended for use as an aid in prosthetic rehabilitation. The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic The Nobol Elocal o Eygoniant and is intended for use as an aid in prosthetic rehabilitation.
    Device Description
    The Zygoma Angled Abutment is an artificial tooth abutment designed to fit and function on Nobel Biocare's Zygoma implant.
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    K Number
    K050641
    Device Name
    ZYGOMA TIUNITE
    Manufacturer
    NOBEL BIOCARE USA LLC
    Date Cleared
    2005-04-07

    (24 days)

    Product Code
    NHA, DZE
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOBEL BIOCARE USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nobel Biocare's Zygoma TiUnite® is a titanium, endosseous implant with components intended to be placed in the upper jaw in order to provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function.
    Device Description
    Nobel Biocare's Zygoma TiUnite® includes endosseous implants, a cover screw, healing abutments, and multi-unit abutments.
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