LogoFDA 510(k) Search
Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K012427
    Device Name
    PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
    Manufacturer
    SPECIALITES SEPTODONT
    Date Cleared
    2001-10-09

    (70 days)

    Product Code
    EAT
    Regulation Number
    872.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIALITES SEPTODONT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pharmaéthyl® Local pulp and vitality testing agent is indicated as topical pulp and tooth vitality testing agent.
    Device Description
    Not Found
    Ask a Question
    K Number
    K010415
    Device Name
    ISODAN
    Manufacturer
    SPECIALITES SEPTODONT
    Date Cleared
    2001-07-23

    (161 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIALITES SEPTODONT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K982773
    Device Name
    QUICKSET LIQUID AND POWDER
    Manufacturer
    SPECIALITES SEPTODONT
    Date Cleared
    1998-11-03

    (88 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIALITES SEPTODONT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quickset™ is a quick-setting temporary restorative material.
    Device Description
    Quickset™ Liquid and Powder
    Ask a Question
    K Number
    K982671
    Device Name
    SECURALLOY
    Manufacturer
    SPECIALITES SEPTODONT
    Date Cleared
    1998-10-19

    (80 days)

    Product Code
    EJJ
    Regulation Number
    872.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIALITES SEPTODONT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SECURALLOY ™ is a dental amalgam for use in the obturation of the cavities of posterior teeth and building of false stumps.
    Device Description
    Not Found
    Ask a Question
    K Number
    K980633
    Device Name
    ENDOSOLV E
    Manufacturer
    SPECIALITES SEPTODONT
    Date Cleared
    1998-05-01

    (71 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIALITES SEPTODONT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Softening and removal of root canal fillings
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1