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510(k) Data Aggregation

    K Number
    K130618
    Device Name
    SFI-ANCHOR
    Manufacturer
    CENDRES & METAUX SA
    Date Cleared
    2014-03-03

    (361 days)

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

    **CENDRES **& METAUX SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SFI-Anchor® D20 is intended for the fixation of (dental) prostheses to corresponding dental implants. The compatible implant systems are specified in Table 1 below. The SFI-Anchor® CD20 is intended as an additional retaining element on CAD / CAM milled dental bars.
    Device Description
    The SFI-Anchor® D20 is an endosseous dental implant abutment for the fixation of (dental) prostheses to the following ITI Dental Implant System® / Straumann® Dental Implant Systems: Standard Ø 4.1 mm Regular Neck (RN) / Standard Ø 4.8 mm Regular Neck (RN) / Standard Plus Ø 4.1 mm Regular Neck (RN) / Standard Plus Ø 4.8 mm Regular Neck (RN) / Tapered Effect Ø 4.1 mm Regular Neck (RN) / Bone Level Ø 4.1 mm, Regular CrossFit® (RC) / Bone Level Ø 4.8 mm, Regular CrossFit® (RC). The SFI-Anchor® CD 20 is intended as an additional retaining element on dental bars. The SFI-Anchor® D20 are straight abutments with gingival heights ranging from 1mm to 5 mm. The SFI-Anchor® CD 20 is a straight bar attachment. The SFI-Anchor® Housing and the SFI-Anchor® Retention Inserts can correct for up to 10° of divergence (20° of divergence between two implants). The SFI-Anchor® is offered in a diameter 4.8 mm. The SFI-Anchor® D20 is connected to the corresponding implants via a mating screw thread and interface geometry. The SFI-Anchor® CD20 is directly screwed on a dental bar construct. The SFI-Anchor® Housing is cemented in the dental prostheses. The SFI-Anchor® Housing, along with an SFI-Anchor® Retention Insert, allow connection of the prosthesis to the abutment / bar attachment by retention-grip. The abutments / bar attachment are machined from Titanium Alloy conforming to ASTM F-136. Other SFI-Anchor® key functional parts are made out of Elitor® (conforming to standard ISO 22674) and of Pekkton® conforming to standard ASTM D3418, ASTM D638 and ASTM D790.
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    K Number
    K131526
    Device Name
    SFI-BAR
    Manufacturer
    CENDRES & METAUX SA
    Date Cleared
    2013-09-23

    (118 days)

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

    **CENDRES **& METAUX SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SFI-Bar® is intended to be used with the implant manufacturer's implant (Table 1) to provide support for fixation of overdentures.
    Device Description
    The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar@ consists of an implant adapter (abutinent) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.
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    K Number
    K123638
    Device Name
    PEKKTON IVORY
    Manufacturer
    CENDRES & METAUX SA
    Date Cleared
    2013-02-21

    (87 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    **CENDRES **& METAUX SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pekkton® ivory is intended to be used for long-term, temporary dental crowns and bridges frameworks.
    Device Description
    Pekkton® ivory is a semi-crystalline thermoplastic supplied in blanks. Pressing the blank gives a framework, from which the dental technician manufactures the final veneered dental crown and / or temporary dental bridge.
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    K Number
    K111390
    Device Name
    SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..
    Manufacturer
    CENDRES & METAUX SA
    Date Cleared
    2011-09-12

    (117 days)

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

    **CENDRES **& METAUX SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SFI-Bar® is intended to be used with the implant manufacturer's implant (TABLE a) to provide support for fixation of overentures.
    Device Description
    The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.
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    K Number
    K102382
    Device Name
    SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT
    Manufacturer
    CENDRES & METAUX SA
    Date Cleared
    2010-12-03

    (102 days)

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

    **CENDRES **& METAUX SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SFI-Bar® is intended to be used with the implant manufacturer's . (Table 1) implant to provide support for fixation of overdentures.
    Device Description
    The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.
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    K Number
    K083876
    Device Name
    SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT
    Manufacturer
    CENDRES & METAUX SA
    Date Cleared
    2010-02-26

    (424 days)

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

    **CENDRES **& METAUX SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SFI-Bar® is intended to be used with the SPI Element Platform 4.0 mm implant (K070007) to provide support for fixation of overdentures. The SFI Bar consists of the following variants: SFI-Bar® 2 Implant: Lower jaw: Connecting 2 or 2x2 implants in the intraforaminal region Upper jaw: Connecting 2x2 implants in the anterior/premolar region SFI-Bar® 4 Implant: Lower jaw: Connecting 4 implants in the intraforaminal region Upper jaw: Connecting 4 implants in the anterior/premolar region
    Device Description
    Not Found
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