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Found 22 results

510(k) Data Aggregation

    K Number
    K152826
    Device Name
    NoCord
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2016-05-27

    (241 days)

    Product Code
    ELW, MVL
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CENTRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NoCord with astringent is a low viscosity vinyl polysiloxane impression material which is indicated for use as the wash material when the tray/wash technique is performed for indirect dental restorations. When applied as the wash material, NoCord 1. Retracts the gingival tissue to expose the sub-gingival margin 2. Controls gingival bleeding 3. Reproduces the structure of a patient's teeth and gums
    Device Description
    NoCord is a low viscosity vinyl polysiloxane impression material.
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    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?
    Applicant Name (Manufacturer) :

    CENTRIX, INC.

    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
    K120176
    Device Name
    SENZZZZZ AWAY
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2012-07-25

    (187 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    CENTRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To relieve dental hypersensitivity.
    Device Description
    Senzzzzz Away is an oxalate tooth desensitizing agent intended for over-the-counter-use. The combination of tubule occlusion and reduction in nerve excitability shown with oxalate formulations is responsible for the reduction in dentinal hypersensitivity to cold, hot and sweets. Senzzzzz Away is a one-part, opaque gel for single use.
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    K Number
    K111348
    Device Name
    RE / STASIS (TM) GINGIVAL RETRACTION PASTE
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2011-07-22

    (70 days)

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

    CENTRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Re/Stasis™ is a paste containing kaolin clay and aluminum chloride, and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. These procedures include dental impressions, restorations, seating of temporary and permanent restorations, placement of rubber dam, and other procedures.
    Device Description
    Re/Stasis™ is a paste containing kaolin clay and aluminum chloride
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    K Number
    K092384
    Device Name
    LIQUICORD
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2009-11-04

    (91 days)

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

    CENTRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LiquiCord is intended for temporary retraction and hemostatsis of the gingival margin during dental procedures such as dental impressions and the seating of temporary and permanent restorations
    Device Description
    Not Found
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    K Number
    K091380
    Device Name
    CORDCAP
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2009-07-30

    (80 days)

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

    CENTRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CordCap™ is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means.
    Device Description
    CordCap™ is a compression roll manufactured out of wicking paper and impregnated with natural salts.
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    K Number
    K021131
    Device Name
    CHLORAPREP
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2002-09-26

    (171 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    CENTRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLEANING AND Disinfective RESTORA ીચ્ચનો work
    Device Description
    Not Found
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    K Number
    K021146
    Device Name
    D/SENSE 1-STEP
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2002-07-02

    (84 days)

    Product Code
    EJK
    Regulation Number
    872.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    CENTRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K010133
    Device Name
    VERSALUX
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2001-04-05

    (78 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    CENTRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001050
    Device Name
    CALCIJECT
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2000-07-21

    (112 days)

    Product Code
    EJK
    Regulation Number
    872.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    CENTRIX, INC.

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