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510(k) Data Aggregation

    K Number
    K024252
    Device Name
    MATCH MASTER LOW FUSION PORCELAIN
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    2004-01-22

    (395 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DAVIS SCHOTTLANDER **& DAVIS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Match Master low fusing porcelain is to be used in conjunction with metal or pressable ceramic framework in the construction of crowns and/or bridgework.
    Device Description
    Not Found
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    K Number
    K024250
    Device Name
    MATCH PRESS PRESSABLE CERAMIC
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    2003-08-25

    (245 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DAVIS SCHOTTLANDER **& DAVIS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Match Press pressable ceramic is to be used in the construction of crown substructures to be veneered with conventional porcelain. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
    Device Description
    Not Found
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    K Number
    K001463
    Device Name
    SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    2000-06-16

    (37 days)

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

    **DAVIS SCHOTTLANDER **& DAVIS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993717
    Device Name
    ENIGMA HI-BASE DENTURE BASE MATERIAL
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    1999-12-22

    (49 days)

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

    **DAVIS SCHOTTLANDER **& DAVIS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENIGMA denture base is to be used in conjunction with denture teeth in the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
    Device Description
    Schottlander ENIGMA HI-BASE Denture base material
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    K Number
    K984134
    Device Name
    NATURA DENTURE TEETH
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    1999-02-12

    (86 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DAVIS SCHOTTLANDER **& DAVIS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NATURA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
    Device Description
    Not Found
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    K Number
    K984128
    Device Name
    ENIGMA DENTURE TEETH
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    1999-02-09

    (83 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DAVIS SCHOTTLANDER **& DAVIS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENIGMA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
    Device Description
    Schottlander ENIGMA denture teeth
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    K Number
    K960770
    Device Name
    MATCHMAKER/PROPAQUE PORCELAIN
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    1996-11-19

    (267 days)

    Product Code
    ELL
    Regulation Number
    872.3920
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DAVIS SCHOTTLANDER **& DAVIS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.
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