LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023742
    Device Name
    SCULPTURE PLUS NANO-HYBRID COMPOSITE
    Manufacturer
    PENTRON LABORATORY TECHNOLOGIES
    Date Cleared
    2003-01-17

    (71 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K932154
    Why did this record match?
    Device Name :

    SCULPTURE PLUS NANO-HYBRID COMPOSITE

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

    Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material. It is indicated for use, in cured form, to restore carious lesions or structural defects or lost tooth structure either by itself or in combination of metal/ceramic/polymeric substrates and conditioners such as bonding, luting, etching agents commonly used in tooth restoration. The curing can be processed using photo and/or heat curing devices. The curing can accomplished in air, under vacuum or under pressure without or with inert atmosphere.

    Device Description

    Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    The document is a 510(k) summary for a dental restorative material, Sculpture Plus Nano-Hybrid Composite, stating its substantial equivalence to a predicate device. It focuses on regulatory approval based on equivalence, not on performance studies with specific acceptance criteria as you've outlined.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1