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510(k) Data Aggregation

    K Number
    K001309
    Device Name
    HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250
    Manufacturer
    KAY SEE DENTAL MFG. CO.
    Date Cleared
    2000-06-13

    (49 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAY SEE DENTAL MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992609
    Device Name
    HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400
    Manufacturer
    KAY SEE DENTAL MFG. CO.
    Date Cleared
    1999-09-22

    (49 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAY SEE DENTAL MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydro-Cast / Kay-See Dental Silicone Soft Liner is applied to acrylic dentures for the purpose of providing a soft tissuebearing surface to the denture for patient comfort.
    Device Description
    Not Found
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    K Number
    K991161
    Device Name
    HYDRO-CAST ACRYLIC VARNISH, MODEL 78125
    Manufacturer
    KAY SEE DENTAL MFG. CO.
    Date Cleared
    1999-04-29

    (22 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAY SEE DENTAL MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydro-Cast Acrylic Varnish is applied to cured materials such as dentures, partial dentures, dental splints and temporary crowns/bridges for the purpose of sealing the acrylic surface.
    Device Description
    Acrylic varnish. Preparation of methyl methacrylate monomer, multifunction methacrylates, light sensitizer, polymerization.
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    K Number
    K990306
    Device Name
    HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
    Manufacturer
    KAY SEE DENTAL MFG. CO.
    Date Cleared
    1999-03-03

    (30 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAY SEE DENTAL MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydro-Cast Dental Etching Gel is used to prepare the surface of the tooth before a dental adhesive is used. It is applied directly on the tooth, and after fifteen seconds, the tooth is rinsed and dried.
    Device Description
    The Hydro-Cast Etching Gel is a 35% phosphoric acid solution. It can be applied with a micro-brush, syringe, or pipette.
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    K Number
    K990155
    Device Name
    HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010
    Manufacturer
    KAY SEE DENTAL MFG. CO.
    Date Cleared
    1999-02-25

    (37 days)

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

    KAY SEE DENTAL MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydro-Cast Versa-Temp Eugenol-Free Provisional Cement is used for temporarily cementing crowns and bridges. Hydro-Cast Versa-Temp provides for easy seating of the temporary, very fast first stage cure with an excellent consistency that allows the removal of excess material from the work area and undercuts, and a rigid set combined with easy removal of the temporary.
    Device Description
    The device is a syringe dispensing system that dispenses a eugenol free temporary dental cement
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