LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082171
    Device Name
    GRADIA CORE
    Manufacturer
    GC AMERICA, INC
    Date Cleared
    2008-10-30

    (90 days)

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

    GRADIA CORE

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

    GRADIA CORE consists of the two articles, GRADIA CORE cartridge and GRADIA CORE self-etching bond. GRADIA CORE cartridge is a two-paste (base and catalyst) type, dual-cured composite resin filled in double syringe to provide auto-mixing system. GRADIA CORE self-etching bond is a two-liquid (A and B), dual-cured self-etching bonding agent to be used for bonding of GRADIA CORE cartridge to the prepared tooth. GRADIA CORE is intended to be used for restoration, core build-up and post cementation.

    Device Description

    GRADIA CORE consists of the two articles, GRADIA CORE cartridge and GRADIA CORE self-etching bond. GRADIA CORE cartridge is a two-paste (base and catalyst) type, dual-cured composite resin filled in double syringe to provide auto-mixing system. GRADIA CORE self-etching bond is a two-liquid (A and B), dual-cured self-etching bonding agent to be used for bonding of GRADIA CORE cartridge to the prepared tooth.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter regarding a 510(k) premarket notification for a dental device called "GRADIA CORE," confirming its substantial equivalence to legally marketed predicate devices. It discusses regulatory compliance and general information but does not include any performance study data or acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1