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    K Number
    K171922
    Device Name
    Anatotemp Anatomic Dental Implant Healing Abutment
    Date Cleared
    2017-09-28

    (93 days)

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

    Buckeye Medical Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Anatotemp Anatomic Dental Implant Healing Abutment is a pre-manufactured healing abutment intended for use with endosseous root-form dental implants to aid in prosthetic rehabilitation. The abutment is a temporary device that aids in creating an esthetic emergence through the gingiva during the healing period. The single use, sterilized device is used by dental professionals during the dental implant healing process and is removed prior to permanent prosthetic placement. Anatotemp Anatomic Dental Implant Healing Abutments are compatible with the following implant systems: | Implant Brand and Type | Implant Platform Size | |----------------------------|--------------------------------| | Implant Direct Legacy | 3.5mmD, 4.5mmD, 5.7mmD | | Implant Direct ReActive | 3.5mmD, 4.3mmD, 5.0mmD | | Implant Direct RePlus | 3.5mmD, 4.3mmD, 5.0mmD | | Implant Direct RePlant | 3.5mmD, 4.3mmD, 5.0mmD, 6.0mmD | | Implant Direct SwishPlus | 4.8mmD, 6.5mmD | | Implant Direct InterActive | 3.0mmD, 3.4mmD | | Implant Direct SwishActive | 3.0mmD, 3.4mmD | | Blue Sky Bio Quattro | Regular Platform (RP) |
    Device Description
    The Anatotemp Anatomic Dental Implant Healing Abutment product line includes anatomically shaped temporary dental implant healing abutments that aid in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments are made of a polymethylmethacrylate biocompatible plastic and are held securely to an endosseous implant with a titanium abutment screw. Anatotemp Anatomic Dental Implant Healing Abutments are positioned well below the occlusal plane and are non-load bearing components that guide healing tissue. Anatotemp Anatomic Dental Implant Healing Abutments are designed not to be in occlusion or sustain occlusal forces. Anatotemp Anatomic Dental Implant Healing Abutments come in six shapes that mimic original tooth shape at the gingival level and also exhibit a mild, biconcave shape interproximally that aids in creating an esthetic emergence through the gingiva during the healing period. Anatotemp Anatomic Dental Implant Healing Abutments exhibit anti-rotational connections that are compatible with many dental implant connections. Anatotemp Anatomic Dental Implant Healing Abutments are provided sterile, are single use, and are recommended for temporary placement of no longer than 180 days. Anatotemp Anatomic Dental Implant Healing Abutments are removed after dental implant healing (approximately 90-180 days) and replaced by the permanent abutment and crown.
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