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510(k) Data Aggregation

    K Number
    K162853
    Device Name
    Bonafix TWO - Dental Implant System
    Manufacturer
    BONAFIX SURGICAL AND DENTAL IMPLANTS
    Date Cleared
    2017-07-14

    (276 days)

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

    BONAFIX SURGICAL AND DENTAL IMPLANTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bonafix TWO Dental Implant System is indicated for delayed loading in surgical and restorative applications placement in the upper or lower jaw and to provide support for prosthetic devices such as artificial teeth with the goal of restoring the patient's chewing function.
    Device Description
    Bonafix TWO Implant is a bone level type implant indicated for delayed loading only, built in Grade 5 ELI Titanium Alloy and treated with RBM technology. To prevent unnecessary rotations between the implant and the abutment, the implant has an internal hex connection style. The body of the implant is tapered, the implant neck is straight and has micro-rings; and the apex of the implant has a dome shape. Was designed with a double-thread that has a constant depth and thickness. Has two-spiral channel at the apical end of the implant that provide self-tapping properties to the implant. This system has 3.35, 3.75, 4.20, 5.00, 6.00 diameter distributed in three (3) platform (Narrow, Standard and Wide) and 8, 10, 11.5, 13 and 15 mm lengths. The 3.35 mm diameter excludes the 8 mm length, and the 6.00 mm diameter excludes the 15 mm length. The implants are provided sterile and are ready to be implanted. The system includes various prosthetic device such as, Cover screw, Healing caps, and two (2) abutments, Straight abutments and Angle abutments are connected to implant through the hex and secured by retained screw. The Straight abutment has 2 to 3 emergence profiles depending on platform. The Angle abutments has a single emergence profile by platform. The angle abutment has axis inclined of 20° compared to the implant's axis. The abutments are provided non-sterile and are intended to be sterilized before use. All prosthetic device are made in Grade 5 ELI Titanium Alloy.
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    K Number
    K122052
    Device Name
    MINIFIX BALL MINIFIX ONE
    Manufacturer
    BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC
    Date Cleared
    2012-11-28

    (139 days)

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

    BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proposed MiniFix Implant system consists of MiniFix One and MiniFix Ball implants. The MiniFix One implants are indicated to provide support for single unit dental prostheses in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The MiniFix One implant must be splinted if two or more are used adjacent to each other. The MiniFix One implant may be immediately restored with a temporary prosthesis that is not in functional occlusion. The MiniFix Ball implants are intended to be placed throughout the maxillary and mandibular arches to provide support for multi-unit restorations on long-term or short term fixation of upper and lower dentures. Immediate loading should only be done in the presence of primary stability and appropriate occlusal loading.
    Device Description
    Built in Grade 5 ELI Titanium Alloy and treated with RBM technology, the proposed MiniFix implants are designed for both provisional and permanent implementations of singleunit or multi-unit restorations. The major component of the MiniFix Implant consists of a one-piece, root-form, self-tapping screw. This implant is offered in two models, each with its own applicability: MiniFix Ball and MiniFix One. The MiniFix Ball implant provides a spherical head that allows for easy placement and removal of both partial and full dentures. Additionally, this model is available in an option without the RBM treatment for use in transitional applications (temporary dentures). Minifx One is a single piece implant that provides a flat head for permanent installation of single crowns.
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    K Number
    K113650
    Device Name
    ORTHOFIX SCREW
    Manufacturer
    BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC
    Date Cleared
    2012-10-03

    (296 days)

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

    BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proposed OrthoFix Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for a single use only. For use in adolescents greater than age 12 and adults.
    Device Description
    The OrthoFix Screw is fabricated from titanium Alloy, which meets the material requirements specified in the ASTM standard ASTM F-136-08. The head on the proximal portion of the screw incorporates a recess, which provides an option for the orthodontist to pass through a wire and tie it in the neck of the OrthoFix Screw in the orthodontic treatment. Distal to the recess is a square indentation that is used as a screw head for screwing the OrthoFix Screw with an instrument, insertion handle tip that is connected to a commercially available insertion handle. The insertion handle tip is manufactured with a medical grade stainless steel 316L. The smooth neck distal to the proximal head employs a hole through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Distal to the neck is the collar, which has a tapered design to protect the soft tissue. The distal portion of the proposed OrthoFix Screw is threaded for quick insertion and provides stability and bio mechanic retention once the screw is fully inserted. The distal tip of the screw is machined with high precision manufacturing to aid the orthodontist in self screwing or self drilling.
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