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510(k) Data Aggregation

    K Number
    K051573
    Device Name
    TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
    Manufacturer
    DR. HOWARD MARTIN, P.A.
    Date Cleared
    2006-06-26

    (377 days)

    Product Code
    EKM
    Regulation Number
    872.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    DR. HOWARD MARTIN, P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gutta percha is inserted into rout canal following root canal preparation.
    Device Description
    Not Found
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    K Number
    K973636
    Device Name
    MCS-MEDICATED CANAL SEALER
    Manufacturer
    DR. HOWARD MARTIN, P.A.
    Date Cleared
    1998-07-27

    (306 days)

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

    DR. HOWARD MARTIN, P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the sealing of prepared root canals in adult or decidious teeth prior to final filling with gutta percha or other acceptable root canal filler. Used to seal canal walls, to promote healing effects and to help preserve the sealer and sealer / gutta percha interface.
    Device Description
    MCS - Martin's Canal Sealer
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    K Number
    K971641
    Device Name
    ANTIBACTERIAL GUTTA PERCHA
    Manufacturer
    DR. HOWARD MARTIN, P.A.
    Date Cleared
    1997-07-21

    (80 days)

    Product Code
    EKM
    Regulation Number
    872.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    DR. HOWARD MARTIN, P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the final filling of prepared root canals in adult or decidious teeth when antibacterial activity is desired in the final filling agont. Used to promote healing effects and to help provent bacterial contamination of the canal. A root canal filler with antibacterial properties indicated in cases whore antibacterial properties coupled with excellent physical characteristics for complete filling of the root canal are needed.
    Device Description
    Antibacterial Gutta Percha
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