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    K Number
    K200573
    Device Name
    BoneTrust Mini Implant System
    Manufacturer
    Medical Instinct Deutschland GmbH
    Date Cleared
    2021-05-14

    (435 days)

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

    Medical Instinct Deutschland GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BoneTrust® Mini and Mini+ Implants are intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implant(s). Use of BoneTrust® Mini and Mini+ Implants is not to exceed one hundred and eighty (180) days. BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments are intended for use with BoneTrust® Mini / Mini+ Dental Implants to provisional prosthetic reconstructions during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments is not to exceed one hundred and eighty (180) days. BoneTrust® Mini Ball Attachments are intended to be used with BoneTrust® Mini / Mini+ Dental Implants to support and/or retain provisional removable dental prostheses during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Ball Attachments is not to exceed one hundred and eighty (180) days.
    Device Description
    The BoneTrust® Mini Implant System is a two-piece dental implant system including various sizes of threaded root-form dental implants and abutments to provide temporary support of prosthetic restorations in edentulous or partially edentulous patients during the healing phase of permanent endosseous dental implant(s). The maximum duration of intraoral use of all members of the BoneTrust® Mini Implant System is 180 days.
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    K Number
    K182313
    Device Name
    BoneTrust Implant System
    Manufacturer
    Medical Instinct Deutschland GmbH
    Date Cleared
    2019-03-11

    (196 days)

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

    Medical Instinct Deutschland GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BoneTrust® Dental Implants are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function. BoneTrust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading. BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only BoneTrust® Abutments and Prosthetic parts are intended for use with Bone Trust Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentulous or partially edentulous patients.
    Device Description
    The BoneTrust® Implant System includes various sizes of threaded root-form dental implants and abutments intended to support prosthetic restorations in edentulous or partially edentulous patients. The BoneTrust® Implants are bone level, root form implants constructed of commercially pure titanium (Grade 4) per ISO 5832-2, with a sand-blasted, acid-etched surface treatment. BoneTrust® Implants are screw- shaped dental implants with a Hexagon or conical torx internal connection. BoneTrust® Dental Abutments are intended for cement-retained and screw-retained restorations. A cylindrical internal hexagon or conical torx allows connection to the BoneTrust® implant. BoneTrust® Dental Abutments are available in different designs
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