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510(k) Data Aggregation

    K Number
    K210186
    Device Name
    PacBond One
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2021-07-16

    (172 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PacBond One

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

    Direct Indications:

    1. light-cured composite and compomer restorations
    2. composite/ceramic/amalgam/metal repairs, cavity sealing for amalgam restorations
    3. light-cured or dual-cured core build-ups

    Indirect Indications:

    1. veneers, porcelain, composite, and metal-based inlays, onlays, crowns, bridges
      endodontic posts
    2. cavity sealing as a pretreatment for indirect restoration
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a U.S. FDA 510(k) clearance letter for a dental bonding agent called "PacBond One." It does not contain any information about acceptance criteria, device performance, clinical study details, or AI/software performance evaluations.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document. The document primarily focuses on:

    • The FDA's determination of substantial equivalence for "PacBond One" to legally marketed predicate devices.
    • Regulatory requirements and guidelines applicable to the device.
    • Indications for Use for the device.

    To answer your questions, I would need a document that describes the clinical or performance studies conducted for the PacBond One device, including details on its testing methodology and results.

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