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510(k) Data Aggregation

    K Number
    K073539
    Device Name
    PROVISA CEM
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2008-01-31

    (45 days)

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

    CAVEX HOLLAND B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PROVISA CEM is intended for the cementation of temporary crowns and bridges. PROVISA CEM is free of eugenol. After its removal, it will also not inhibit the polymerisation of a composite cement or composite filling material.
    Device Description
    PROVISA CEM is a dental cement and is particularly intended for the cementation of temporary crowns and bridges. Such a temporary prosthesis is a necessity for the patient in the period between the preparation of the tooth (or teeth) stump, followed by the impression taking, and the placement and cementation of the final prosthesis. During this period of one week or more, the prepared tooth stump has to be protected against any damage. But also the occlusal relationship of the tooth stump versus neighbouring and antagonist teeth has to be kept unchanged in order to prevent articulation problems upon placing the final prosthesis. A temporary cement should offer sufficient retentive force to keep the temporary prosthesis in situ during the intervening week(s), but at the same time it should enable the dentist to take the prosthesis off without damaging the tooth stump and with no discomfort for the patient. PROVISA CEM is presented in the form of two pastes: a white paste, containing zincand magnesium oxide as the reactive components and a yellow paste, containing fatty acid dimer as the reactive component. Upon mixing homogeneously, controlled by a uniform light yellow colour, a smooth paste with the correct consistency is formed, that can be pressed into a thin, but sufficiently strong cement layer. Through a reaction between the metallic oxides and the fatty acid dimer, a chelatenetwork is formed, that makes the paste harden. The resulting cement is stable and strong enough but not too strong.
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    K Number
    K072245
    Device Name
    EMULATE ADVANCED
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2007-11-08

    (87 days)

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

    CAVEX HOLLAND B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K062400
    Device Name
    IMPRESSIX, COLORCHANGE ALGINATE
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2006-11-16

    (92 days)

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

    CAVEX HOLLAND B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ImprEssix, Colorchange Alginate is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
    Device Description
    ImprEssix, Colorchange Alginate is a dental impression material based on alginate.
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    K Number
    K061267
    Device Name
    SIMULATE, COLOR CHANGE ALGINATE
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2006-07-10

    (66 days)

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

    CAVEX HOLLAND B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Simulate, Color Change Alginate is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc. Simulate, Color Change Alginate has the special characteristic of being a colorchanging alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.
    Device Description
    Simulate, Color Change Alginate is a dental impression material based on alginate. It has the special characteristic of being a colorchanging alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.
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    K Number
    K052455
    Device Name
    IMPRESSIX
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2005-11-23

    (77 days)

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

    CAVEX HOLLAND B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour. Therefore, ImprEssix is particularly suited for orthodontics
    Device Description
    ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour.
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    K Number
    K051207
    Device Name
    CAVEX ORTHOTRACE
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2005-06-21

    (41 days)

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

    CAVEX HOLLAND B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cavex Orthotrace alginate impression material is a dental impression material based on alginate. It is about taking impressions of the oral cavity with the purpose of constituting a gypsum cast that is a copy of the situation in the mouth. Cavex Orthotrace has an extra fast setting, high elasticity, high tear resistance, can be poured twice with gypsum and is proven Orthotrace is particularly suited for orthodontics
    Device Description
    Cavex Orthotrace Alginate impression material
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    K Number
    K042806
    Device Name
    QUADRANT UNIT-1-BOND
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2004-11-24

    (43 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAVEX HOLLAND B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.
    Device Description
    Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.
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    K Number
    K032116
    Device Name
    TULIP COLORSWITCH
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2003-09-30

    (83 days)

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

    CAVEX HOLLAND B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tulip Colorswitch is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
    Device Description
    Tulip Colorswitch is a dental impression material based on alginate. Tulip Colorswitch has the special characteristic of being a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.
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    K Number
    K023466
    Device Name
    TULIP ALGINATE IMPRESSION MATERIAL
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2002-12-13

    (58 days)

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

    CAVEX HOLLAND B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tulip Alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
    Device Description
    Tulip Alginate impression material is a dental impression material based on alginate.
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    K Number
    K020242
    Device Name
    EMULATE FAST SET AND EMULATE REGULAR SET
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2002-04-17

    (84 days)

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

    CAVEX HOLLAND B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    emulate Fast Set and emulate Regular Set are dental impression materials based on alginate. They are suitable for taking impressions of the oral cavity with the purpose of constructing a gypsum model that equals the situation in the mouth. They are used for making study models, first impressions for general purpose impressions, situation models, orthodontic impressions etc.
    Device Description
    emulate Fast Set & emulate Regular Set Alginate Impression Materials
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