LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K181037
    Device Name
    DIO CAD/CAM Abutment
    Manufacturer
    DIO Corporation
    Date Cleared
    2018-12-21

    (246 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K111421,K143505,K112730,K161987,K122519,K170608,K073173,K131117,K150203
    Why did this record match?
    Reference Devices :

    K111421, K143505, K112730, K161987, K122519, K170608, K073173, K131117

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

    DIO CAD/CAM Abutment is 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.

    Patient specific abutment is intended for use with the UF Implant Systems provided in the chart. All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.

    Device Description

    The DIO CAD/CAM Abutment includes two CAD/CAM abutment designs, Hybrid Link Abutment and Patient-Specific Abutment.

    1. Hybrid Link abutment: Hybrid Link abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The hybrid link abutment is composed of two-piece abutment that is a hybrid link at the bottom and a coping (CAD/CAM patient specific superstructure) at the top. The hybrid link abutments are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136. The diameters of Hybrid Link Abutment are 4.0/4.5/5.5mm. Hybrid Link abutment is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the Hybrid Link Abutment.

    2. Patient-Specific Abutment: Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician. The diameters of patient-specific Abutment are 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 and two connection designs (Hex, Non-hex). Patient-specific abutments are supplied with an abutment screw previous cleared device as K122519 and K161987 and provided non-sterile.

    AI/ML Overview

    The document provided is a 510(k) Premarket Notification from the FDA for a dental implant abutment. It does not describe a study involving an AI/ML device, nor does it provide acceptance criteria or performance metrics in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices through material properties, design specifications, and non-clinical testing for dental implant abutments.

    Therefore, I cannot provide the requested information regarding acceptance criteria and device performance from this document. The sections you asked for, such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, are not applicable to the content of this 510(k) summary for a physical medical device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1