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510(k) Data Aggregation

    K Number
    K991902
    Device Name
    LC PIT & FISSURE SEALANT
    Manufacturer
    BOSWORTH CO.
    Date Cleared
    1999-07-26

    (52 days)

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

    LC Pit & Fissure Sealant is a clear, light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth, and restorations to help protect against caries.

    Device Description

    LC Pit & Fissure Sealant is a clear, light-activated dental sealant.

    AI/ML Overview

    This document is a 510(k) clearance letter for a dental sealant. It does not contain information regarding acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria.

    The information provided in the letter is limited to:

    • Device Name: LC Pit & Fissure Sealant
    • Regulatory Class: II
    • Product Code: EBC
    • Intended Use/Indications for Use: "LC Pit & Fissure Sealant is a clear, light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth, and restorations to help protect against caries."
    • Date of Submission and Clearance.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study to prove their fulfillment based on the provided document. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, not on specific performance metrics or clinical study results.

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