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510(k) Data Aggregation

    K Number
    K162661
    Device Name
    SavDenTM MTA Root Canal Filling Materials
    Manufacturer
    tYDS Biotech Incorporation
    Date Cleared
    2017-04-25

    (211 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K142178
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • A root end filling material.
    • For the repair of root canals as an apical plug during apexification.
    • For repair of root perforations during root canal therapy or as a consequence of internal resorption.
    • As a pulp capping material.
    • Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations.
    Device Description

    SavDen™ MTA powder consists of fine, hydrophilic particles that set in the presence of water. Hydration of the powder creates a colloidal gel that is solidified to form an impermeable barrier that fully cures over a four-week period.

    AI/ML Overview

    This document describes the marketing authorization for a medical device and is not a study that uses an AI/ML powered device, therefore the information required to analyze such a device is not present in the document.

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