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510(k) Data Aggregation

    K Number
    K970134
    Device Name
    THERMAPREP PLUS OVEN
    Manufacturer
    TULSA DENTAL PRODUCTS, LTD.
    Date Cleared
    1997-03-21

    (65 days)

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

    TULSA DENTAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The THERMAPREP® PLUS OVEN is specially developed for heating ThermaFil® endodontic obturators. Do not use the oven for any other purpose.
    Device Description
    The THERMAPREP® PLUS OVEN is a heating unit for obturators. The system allows for individual heating of ThermaFil® gutta percha obturators. Microwave technology is used to produce uniform predictable heating results.
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    K Number
    K964174
    Device Name
    MINERAL TRIOXIDE AGGREGATE (MTA)
    Manufacturer
    TULSA DENTAL PRODUCTS, LTD.
    Date Cleared
    1997-02-10

    (115 days)

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

    TULSA DENTAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated clinical applications include use as repair of pulpal exposures.
    Device Description
    Mineral Trioxide Aggregate (MTA) is a cement-like substance which seals off all pathways of communication between the root canal system and the external surface of the tooth. Indicated clinical applications include use as repair of pulpal exposures. The powder consists of fine hydrophilic particles which set in the presence of moisture. Hydration of the powder results in a colloidal gel which solidifies to a hard structure. Mineral Trioxide Aggregate is biocompatible, and exhibits significantly better adaptation to dentinal walls than other materials. It possesses a high degree of sealability; the presence or absence of blood does not affect its sealing ability. Setting time after hydration and application is approximately three hours. In tests, its compressive strength at 21 days is about 70 Mpa. Use of MTA requires only the appropriate hydration of the powder to a viscous consistency. The mixture can then be placed over the exposure site and gently patted into place using a moistened cotton ball if necessary.
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    K Number
    K954790
    Device Name
    PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS
    Manufacturer
    TULSA DENTAL PRODUCTS, LTD.
    Date Cleared
    1996-01-16

    (89 days)

    Product Code
    DZA
    Regulation Number
    872.4130
    Why did this record match?
    Applicant Name (Manufacturer) :

    TULSA DENTAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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