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510(k) Data Aggregation

    K Number
    K201785
    Device Name
    EPIEN Dental Cleanser
    Manufacturer
    EPIEN Medical, Inc.
    Date Cleared
    2021-09-09

    (436 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIEN Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EPIEN DENTAL CLEANSER is indicated for the following uses: 1) Caries Restoration Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of exposed dentin surfaces in cavity preparations to assist in the removal of contaminated debris and smear-layer. 2) Chronic Periodontitis Treatment Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of tooth root surfaces during periodontal debridement procedures (scaling and root planing) to help with the removal of contaminated debris from the sulcus.
    Device Description
    Not Found
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    K Number
    K123538
    Device Name
    EPIEN ROOT CANAL CLEANSER
    Manufacturer
    EPIEN MEDICAL, INC.
    Date Cleared
    2013-02-01

    (77 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EPIEN ROOT CANAL CLEANSER is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal systems.
    Device Description
    EPIEN ROOT CANAL CLEANSER is an aqueous, moderately viscous and dense solution that is used to irrigate root canals to provide a rinse to tooth surfaces as an adjunctive to professional mechanical dental procedures. The EPIEN ROOT CANAL CLEANSER is applied onto tooth root canal surfaces for a brief duration using standard dental irrigation syringes. It is then rinsed away with saline or water. EPIEN ROOT CANAL CLEANSER cleanses the root canal system by enhancing the removal of the post-instrumentation smear layer. The EPIEN ROOT CANAL CLEANSER consists of hydroxybenzenesulfonic acid, hydroxymethoxybenzenesulfonic acid, sulfuric acid, and water, in addition to a colorant.
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