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510(k) Data Aggregation

    K Number
    K042466
    Device Name
    X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE
    Manufacturer
    ZEST ANCHORS, INC.
    Date Cleared
    2004-11-24

    (72 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE

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

    The X-2 Implant Attachment is designed for use with overdentures or partial dentures, retained in whole or in part by endosseous implants in the mandible or maxilla.

    The X-2 Bar Attachment System is designed for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.

    The X-2 Distal Extension Attachment System is designed for use with partial dentures retained in whole or in part by bar splinted endosseous implants and crowned roots with a distal extension in the mandible or maxilla.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) summary for the "X-2 Implant Bar and Distal Extension" does not contain information about acceptance criteria or a study proving that a device meets those criteria.

    The document is a letter from the FDA granting substantial equivalence for a dental implant abutment system, allowing it to be marketed. It includes:

    • Trade/Device Name: X-2 Implant Bar and Distal Extension
    • Regulation Number and Name: 872.3630, Endosseous Dental Implant Abutment
    • Regulatory Class: II
    • Product Code: NHA
    • Indications for Use: Details for the X-2 Implant Attachment, X-2 Bar Attachment System, and X-2 Distal Extension Attachment System.

    The 510(k) clearance process primarily establishes substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and performance outcomes for new devices. The letter explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

    Therefore, I cannot extract the requested information (acceptance criteria, device performance table, sample sizes, ground truth details, MRMC study, or standalone performance) from the provided text as it focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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