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510(k) Data Aggregation

    K Number
    K210412
    Device Name
    Pac-Dent Ceramic Nanohybrid Resin
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2021-07-26

    (165 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Pac-Dent Ceramic Nanohybrid Resin

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

    Pac-Dent Ceramic Nanohybrid Resin is indicated as a permanent restorative for both anterior restorations, including occlusal surfaces. It is used for fabrications such as inlays, onlays, veneers and full crown restorations.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental material (Pac-Dent Ceramic Nanohybrid Resin). It does not contain information about an AI/ML-based medical device. Therefore, I cannot extract the information required to answer your questions about acceptance criteria and study proving device performance for an AI/ML device.

    The provided text only discusses:

    • The FDA's review and determination of substantial equivalence for a dental resin material.
    • Regulatory information regarding device registration, labeling, good manufacturing practices, and adverse event reporting for this type of medical device.
    • Indications for Use for the dental resin.

    To answer your request, I would need a document related to the clearance or approval of an AI/ML-based medical device.

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