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510(k) Data Aggregation

    K Number
    K251884
    Device Name
    One-Fil Putty Injectable
    Manufacturer
    MEDICLUS CO., LTD.
    Date Cleared
    2025-08-22

    (63 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Special
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K243353
    Why did this record match?
    Device Name :

    One-Fil Putty Injectable

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Furcation or root perforation treatment via canal
    2. Furcation or root perforation treatment via surgical
    3. Internal reabsorption treatment via canal or surgical
    4. External reabsorption treatment
    5. Retrofilling in parendodontic surgery
    6. Direct and Indirect pulp capping
    7. Apexification
    8. Apexogenesis and Pulpotomy
    Device Description

    One-Fil Putty Injectable is a premixed material intended for permanent root canal filling. It is based on a tricalcium silicate composition, which undergoes setting and hardening in the presence of moisture.
    The product is packaged in a paper box with four syringes in a vinyl packaging, and the contents in the glass syringe are white paste type.

    AI/ML Overview

    This FDA 510(k) clearance letter and summary are for a dental material, not an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, ground truth establishment, training set details, and expert qualifications) are not applicable.

    However, I can extract the relevant information regarding the device's acceptance criteria and the study proving it meets them.

    Acceptance Criteria and Device Performance for One-Fil Putty Injectable (K251884)

    The "One-Fil Putty Injectable" is a dental root canal filling material. Its acceptance criteria are based on conformance to international standards for dental materials, specifically ISO 6876, and comparison to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by conformance to ISO 6876 and the performance of the predicate device (One-Fil Putty, K243353). The reported performance of the subject device is directly compared to the predicate device in the 510(k) summary.

    Performance CharacteristicStandard/Acceptance Criteria (Predicate Device Performance)Reported Device Performance (One-Fil Putty Injectable)
    Curing Time
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