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510(k) Data Aggregation

    K Number
    K242768
    Device Name
    Customized Abutment and Screw
    Manufacturer
    Chengdu Besmile Medical Technology Co., Ltd.
    Date Cleared
    2025-09-02

    (354 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    K193425,K234112
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Customized Abutment and Screw is used as a complement component for dental implants placed in the jawbone after tooth loss, to connect, support and retain the restoration or implant superstructure. Customized Abutment and Screw is indicated for single unit restorations.

    Customized Abutment and Screw is compatible with following Implant Systems:

    No.Implant System CompatibilityImplant Body Diameter(mm)Platform Diameter(mm)
    1Straumann Bone Level RC 4.1, RC 4.8 (composed of pure titanium)4.1,4.84.1,4.8
    2Straumann Bone Level NC 3.3 (composed of pure titanium)3.33.3
    3Nobel Biocare Active NP3.53.53.5
    4Nobel Biocare Active RP4.3/5.04.3, 5.03.9, 3.9

    All digitally designed abutments for use with Customized Abutment and Screw are intended to be manufactured at a BESMILE validated milling center.

    Device Description

    The Customized Abutment and Screw is composed of two parts: the customized abutment and screw. Among them, the customized abutment is machined from Ti-6Al-4V titanium alloy material in accordance with ASTM F1472, and the screw is machined from Ti-6Al-4V ELI titanium alloy material in accordance with ASTM F136. And the surface of product is not modified. The lower part of the product has a fixed interface shape, and the upper part is machined according to the needs of the patient. In the process of dental implant surgery, as the upper structure of the implant, it is installed on the implant platform anchored in the bone, which plays the role of supporting, retaining and stabilizing the prosthesis.

    Customized Abutment and Screw is created via use of the Pre-milled Blank.

    The information of the Implant Systems compatible with the product is detailed in Table 1.

    AI/ML Overview

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