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510(k) Data Aggregation

    K Number
    K140144
    Device Name
    BENDA WEDGE
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2014-07-08

    (167 days)

    Product Code
    EJB
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EJB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Benda Wedge is an inter-proximal wedge coated with an astringent to be used in combination with other devices to temporarily retain composite or amalgam restorative material as well as to control gingival bleeding during dental restorations.
    Device Description
    Benda Wedge is indicated for use as a temporary inter-proximal wedge during dental restorative procedures. Benda Wedge is similar in design to the Wedge Wand predicate device but includes a hemostatic agent to control gingival bleeding. Design features consist of the following: Available in four anatomically-shaped sizes for optimum placement in inter-proximal spaces. Use an injection-molded thermoplastic material which is then coated with a fixed amount of aluminum sulfate hexadecahydrate to help control gingival bleeding.
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    K Number
    K023367
    Device Name
    DETECTAR, MODEL N123-MI
    Manufacturer
    NEKS TECHNOLOGIES
    Date Cleared
    2003-06-25

    (260 days)

    Product Code
    EJB, NBL
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EJB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DETECTAR is indicated for use in the detection of subgingival dental calculus. DETECTAR is indicated for the detection of subgingival dental calculus
    Device Description
    The DETECTAR probe is similar in intended use, size, and shape to a manual periodontal probe. The DETECTAR probe contains an optical fiber that reads the optical signature of dental calculus and converts it into an electrical signal. From that electrical signal a computer analysis identifies the dental calculus.
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    K Number
    K981234
    Device Name
    FLARE,FILE, FILL
    Manufacturer
    LONE STAR TECHNOLOGIES
    Date Cleared
    1998-06-05

    (62 days)

    Product Code
    EJB
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EJB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the preparation of root canals prior to the final filling of the root canals in adult or deciduous teeth. The Dentist or Endodontist examines the patient to determine if the method of treatment is to be the removal of the root canal for the appropriate reasons. After opening the tooth with the access bur the first part of the root canal is exposed to the point where the canals tend to branch out about one third of the way. The Dentist then follows his standard procedure of locating the Apex and removal of the nerve and decayed matter from the canal using the Flare--File -- Fill procedures.
    Device Description
    Not Found
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