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    K Number
    K211409
    Device Name
    Proximerge 2 Dental Implant System
    Manufacturer
    Quadric BioMed, LLC
    Date Cleared
    2022-10-19

    (531 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K972417,K171784,K201334,K092035
    Why did this record match?
    Device Name :

    Proximerge 2 Dental Implant System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Proximerge™ 2 Dental Implant System is designed for use in edentulous sites in the mandible or maxilla as a single tooth replacement. These implants are indicated for delayed loading.

    Device Description

    The Proximerge 2TM Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, temporary abutments, and closure screws. The implants are designed with elongation in the mesial-distal dimension. The implants have a 7mm length and a mesial-distal elongated footprint in 4.5x6.3mm, 4.5x7.6mm, 4.5x9.1mm, and 4.5x10.5mm options and are press-fit into the bone. The abutments have a 0° angulation, have post and gingival heights of 4.5mm and 2.4mm respectively for each implant size, and have a tapered implant-abutment interface . Temporary tissue former abutments (also called healing abutments) and healing caps are offered to protect the implant until the abutment is attached; the tissue formers and healing caps have the same angulation and implant-abutment interface as the permanent abutments. An M1.8 capture screw attaches the abutment, the tissue forming abutment, or the healing cap to the implant. All components in the Proximerge™ 2 Dental Implant System are manufactured from Ti-6A1-4V ELI per ASTM F136.

    AI/ML Overview

    The provided text describes a medical device, the Proximerge™ 2 Dental Implant System, seeking 510(k) clearance from the FDA. It details device characteristics, comparisons to predicate devices, and performance data from non-clinical testing. However, it does not include acceptance criteria for an AI/ML powered device, nor does it describe a study involving an AI/ML model's performance.

    Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria or a study proving an AI device meets them based on the input text. The information requested (acceptance criteria table, sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size, etc.) is specifically for AI/ML performance evaluation, which is not present in this document about a dental implant system.

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