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510(k) Data Aggregation

    K Number
    K161713
    Device Name
    Dentium CAD/CAM Abutments
    Manufacturer
    Dentium Co., Ltd
    Date Cleared
    2016-12-16

    (178 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K141457,K070228,K041368,K092341,K150203,K103020
    Why did this record match?
    Device Name :

    Dentium CAD/CAM Abutments

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

    Dentium abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

    All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent to a Dentium-validated milling center for manufacture.

    Device Description

    Dentium CAD/CAM Abutments are titanium abutments to be used in fabricating patient-specific abutments. Each patient-specific abutment is individually prescribed by the clinician. Dentium CAD/CAM Ti-Blank Abutments are abutments with a pre-manufactured precision interface and are used by a validated milling center to fabricate patient-specific abutments. Ti-Blanks are available in three cylinder diameters (10 mm, 14 mm, and 15.8 mm) and three connection designs (Hex, Long Hex). Dentium CAD/CAM Custom Abutments are patient-specific abutments fabricated by Dentium. Custom Abutments are available for fabrication in three connection designs (Hex, Long Hex, and Non-hex). Dentium CAD/CAM Abutments are available for four corresponding implant platform diameters (3.6 mm. 4.0 mm, 4.5 mm, 5.0 mm). Each abutment is supplied with a corresponding abutment screw, cleared previously in K141457. All subject device abutments are compatible with Implantium dental implants.

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) Pre-Market Notification for Dentium CAD/CAM Abutments does not contain any information about acceptance criteria or a study proving that an AI/device meets acceptance criteria related to diagnostic performance.

    The document is a clearance letter for a dental device (CAD/CAM abutments), not an AI or diagnostic imaging device. It focuses on demonstrating substantial equivalence to predicate devices based on:

    • Non-clinical performance data: steam sterilization validation, biocompatibility, and dynamic compression-bending testing.
    • Design similarities: material, size, and interface.
    • Intended use.

    Therefore, I cannot extract the information required by your request, such as a table of acceptance criteria for diagnostic performance, sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, or training set details, because this document is for a medical device that does not involve such diagnostic performance evaluations.

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