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510(k) Data Aggregation

    K Number
    K252286

    Validate with FDA (Live)

    Device Name
    BIORES Dental Implant System
    Manufacturer
    Chengdu Besmile Medical Technology Co., Ltd.
    Date Cleared
    2026-02-02

    (194 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Abbreviated
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K211090,K192347,K171027
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BIORES Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

    Implants with a diameter of 3.7 mm are only suitable for anterior tooth restoration.

    Device Description

    BIORES Dental Implant System includes Implant, Abutment and Accessories. Abutment and Accessories are only compatible with our company's Implant to restore patients' chewing function.

    Implant is made of Titanium Grade 4 material that complies with ASTM F67 and has a sandblasted and acid-etched surface. The implant is supplied sterile and is gamma sterilized. The sterilization is shelf life for 8 years. Implant is classified into Type I Implant and Type II Implant according to different thread designs. Type I Implant feature conical threaded structures, consisting of a top, neck, and body. The top of the implant is machined (0.4mm length), the neck has trapezoidal micro-threads, and the body has large threads in a reverse sawtooth pattern, with rotational cuts at the large thread locations. Type II Implant have a conical threaded design, consisting of a top, and body. The implant body has large threads, and the large thread area has rotational cuts.

    Abutment and Accessories include bonding abutment(straight only), healing abutment, central screw, and cover screw, all made from Ti-6Al-4V ELI titanium alloy material compliant with ASTM F136, without any surface treatment. The bonding abutment is provided non-sterile and must be sterilized by the user using steam sterilization prior to use; the healing abutment, central screw, and cover screw are provided sterile, with a sterilization shelf life of 5 years.

    AI/ML Overview

    N/A

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