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510(k) Data Aggregation

    K Number
    K070084
    Device Name
    MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL
    Manufacturer
    EST. ANTHOGYR
    Date Cleared
    2007-03-08

    (58 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    EST. ANTHOGYR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANTHOGYR's fully autoclavable contra-angles Implantology "MontBlanc" Control are devices intended for a wide range of dental procedures including: Implant surgery such as perforating the bone, tapping and threading procedures This range can be used with special accessories like depth stop.
    Device Description
    ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to N.F. EN ISO 7785-2 "Dental Handpieces -Part 2: Straight and geared angle handpieces: ".
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    K Number
    K060317
    Device Name
    ANTHOGYR CONTRA ANGLES AND HANDPIECES
    Manufacturer
    EST. ANTHOGYR
    Date Cleared
    2006-04-28

    (79 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    EST. ANTHOGYR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANTHOGYR's fully autoclavable contra-angles "MontBlanc" are devices intended for a wide range of dental procedures including: - Implant surgery such as perforating the bone, tapping and threading procedures - General dentistry such as removing carious material, cavity and crow preparation, finishing tooth preparations, restorations and polishing teeth
    Device Description
    ANTHOGYR has developed a full range of surgical, reducing, multiplying and 1:1 contra angle intended to be used in implantology and general dentistry procedures. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared angle handpieces.
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    K Number
    K020431
    Device Name
    FIBIOCORE
    Manufacturer
    EST. ANTHOGYR
    Date Cleared
    2002-07-03

    (145 days)

    Product Code
    ELR
    Regulation Number
    872.3810
    Why did this record match?
    Applicant Name (Manufacturer) :

    EST. ANTHOGYR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FIBIOCORE composite posts are intented for use by dentists to give retention for reconstruction of non-vital teeth. The device is intended to be cemented into the root canal of a tooth to stabilize and support a restoration.
    Device Description
    Glass Fiber composite root canal post
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