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510(k) Data Aggregation

    K Number
    K202269
    Device Name
    PRE-MILLED Abutment
    Date Cleared
    2020-11-25

    (106 days)

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

    MIT Global Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PRE-MILLED Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. It is compatible with the following systems: - Zimmer 3.1mmD Dental Implant System (K142082) - Screw Vent® and Tapered Screw Vent® (K013227) All digitally designed abutments for use with the PRE-MILLED Abutments must be designed and milled through the 3Shape CAD/CAM System and are intended to be sent to a validated milling center for manufacture. The PRE-MILLED Abutment is compatible with the following devices: Zimmer 3.1mmD Dental Implant System (K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex Screw Vent® and Tapered Screw Vent® (K013227) Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex
    Device Description
    The PRE-MILLED Abutment is used in fabricating a patient-specific abutment in titanium alloy. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. It is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system. Mechanical resistance of the implant-abutment connection is essential to ensure the correct longterm functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of abutments and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established. The PRE-MILLED is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices. The proposed abutments are available in internal connection, and are compatible with Zimmer 3.1mmD Dental Implant System (K142082) and Screw Vent® and Tapered Screw Vent® (K013227).
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