LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062886
    Device Name
    ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
    Manufacturer
    CAO GROUP, INC.
    Date Cleared
    2006-11-06

    (41 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K053089,K992326,K963921
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ascent Pit & Fissure Sealant System is applied after the intended surface is prepared, etched, and treated as necessary. The material is applied to the site directly from the material packaging, usually in the form of a syringe or other hand-held dispensing apparatus. The sealant is worked into and around the affected area with a tip or brush to ensure an adequate and thorough coat. The material is then polymerized using a suitable dental polymerization light source. This system is marketed and sold only to licensed professional dentists.

    Ascent Pit & Fissure Sealant is indicated for:

    • The sealing of pits and fissures
    Device Description

    The Ascent Pit & Fissure Sealant System is a comprehensive light-cured system designed to fill and seal the pits and fissures of teeth. The integrated nano-filler technology provides excellent wear and strength properties. The methacrylate based resin system provides an excellent seal and superior adhesion to etched enamel. The system may alternately be supplied either with or without a pretreatment phosphoric acid etchant. The modification made to the device as originally submitted is the addition of a secondary material in the form of a fluoride releasing compound.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and a study proving a device meets those criteria. The document is a 510(k) summary for a dental pit and fissure sealant, focusing on its substantial equivalence to previously marketed devices.

    Specifically, the document states:

    • "Performance Standards: None"
    • "Performance Data: See Part 7: Performance Data" However, "Part 7: Performance Data" is NOT included in the provided text.

    Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

    The document primarily addresses the substantial equivalence of the Ascent Pit & Fissure Sealant to predicate devices based on composition, indications for use, and application methods, with the main change being the addition of a fluoride-releasing compound.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1