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510(k) Data Aggregation

    K Number
    K062044
    Device Name
    THE 5.0 X 6.0MM DENTAL IMPLANT
    Manufacturer
    BICON, INC.
    Date Cleared
    2006-11-21

    (125 days)

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

    BICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 5.0 x 6.0mm locking-taper Bicon dental implant is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices to restore the patient's chewing function.
    Device Description
    The 5.0 x 6.0mm Dental Implant
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    K Number
    K051091
    Device Name
    SYNTHOGRAFT
    Manufacturer
    BICON, INC.
    Date Cleared
    2005-09-01

    (126 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    BICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synthograft is designed for: - the filling and or reconstruction of either traumatic or degenerative multi-wall bone defects - the augmentation of the sinus floor - the augmentation of the alveolar ridges - the augmentation of the alveblar hagos - the filling of periodontal or other alveolar bone defects and tooth sockets and osteotomies - the preservation of the alveolus for the preparation of an implant site.
    Device Description
    Not Found
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    K Number
    K050712
    Device Name
    4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT
    Manufacturer
    BICON, INC.
    Date Cleared
    2005-04-22

    (36 days)

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

    BICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 4.5 x 6.0mm and the 6.0 x 6.0mm implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement.
    Device Description
    Not Found
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    K Number
    K050408
    Device Name
    BICON ORTHODONTIC IMPLANT SYSTEM
    Manufacturer
    BICON, INC.
    Date Cleared
    2005-04-07

    (49 days)

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

    BICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bicon Orthodontic Implant System is intended for those cases where a clinician desires to provide a fixed point of anchorage to which orthodontic appliances may be attached to orthodontically move teeth. The system consists of a small implant that is screwed into the jawbone that will be removed after completion of treatment.
    Device Description
    Not Found
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    K Number
    K031568
    Device Name
    BICONITE SURFACE TREATMENT
    Manufacturer
    BICON, INC.
    Date Cleared
    2004-11-23

    (553 days)

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

    BICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a completed denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement.
    Device Description
    Not Found
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    K Number
    K042637
    Device Name
    THE 5.0 X 6.0MM DENTAL IMPLANT
    Manufacturer
    BICON, INC.
    Date Cleared
    2004-11-15

    (49 days)

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

    BICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 5.0 x 6.0mm Bicon dental implant is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices to restore the patient's chewing function.
    Device Description
    Not Found
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    K Number
    K023705
    Device Name
    BICON TRANSITIONAL IMPLANT (BTI) SYSTEM
    Manufacturer
    BICON, INC.
    Date Cleared
    2003-01-29

    (86 days)

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

    BICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BTI System will be used to provide immediate or interim stability for new/existing dental prosthetics in partially or fully edentulous jaws.
    Device Description
    Not Found
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    K Number
    K010185
    Device Name
    6.0 X 5.7MM DENTAL IMPLANT
    Manufacturer
    BICON, INC.
    Date Cleared
    2002-12-30

    (710 days)

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

    BICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994037
    Device Name
    THE 4.5MM DIAMETER BICON DENTAL IMPLANT
    Manufacturer
    BICON, INC.
    Date Cleared
    2000-01-11

    (43 days)

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

    BICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 4.5mm diameter implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridge work , partial dentures, and / or a single tooth replacement.
    Device Description
    Not Found
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    K Number
    K982488
    Device Name
    BICON BONE SCREW SYSTEM
    Manufacturer
    BICON, INC.
    Date Cleared
    1999-01-26

    (193 days)

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

    BICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bicon Bone Screws are indicated for those cases where a clinician desires to have a temporary prosthesis attached to bone.
    Device Description
    Not Found
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