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510(k) Data Aggregation

    K Number
    K122974
    Device Name
    TRYOUT-VPS HOLDING PASTE
    Manufacturer
    Date Cleared
    2013-05-17

    (233 days)

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

    CROWN DELTA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Crown Delta's TRYOUT – Translucent Shade VPS Holding Paste is to be used for the temporary stabilization of ceramic crowns and veneers on prepared teeth while the dentist evaluates fit, re-contours and/or trims, and performs an esthetic assessment prior to permanent fixation with cement.
    Device Description
    TRYOUT - Translucent Shade VPS Holding Paste
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    K Number
    K041028
    Device Name
    CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL
    Manufacturer
    Date Cleared
    2004-05-14

    (23 days)

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

    CROWN DELTA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Crown Delta's Hydrophilic vinyl polysiloxane impression material will be used for making impressions of the teeth and gums of patients requiring models for study and/or for production inflorotive of the testic devices. The impression material is intended to be applied via a dual be rooterative prosem either into an impression tray or directly onto the patient's teeth. The "hydrophilic" enhancement will enable production of more accurate impression when adverse conditions (e.g. the presence of blood or saliva) are present.
    Device Description
    Crown Delta Hydrophilic Impression Material is a hydrophilic vinyl polysiloxane impression material.
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    K Number
    K955288
    Device Name
    HEARING AID IMPRESSION MATERIAL
    Manufacturer
    Date Cleared
    1996-02-02

    (78 days)

    Product Code
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CROWN DELTA CORP.

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