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510(k) Data Aggregation

    K Number
    K091494
    Device Name
    FLEXITIME FLOW
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2009-07-31

    (72 days)

    Product Code
    ELW, 76E
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERAEUS KULZER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flexitime Light Flow/Flexitime Medium Flow each is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridge, edentulous and partial impressions.
    Device Description
    Dental Impression Material
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    K Number
    K082591
    Device Name
    FLEXITIME BITE
    Manufacturer
    HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
    Date Cleared
    2008-12-05

    (88 days)

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

    HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for standards bite registrations in the end bite position Coating of bite forks Key material for needle point registration Production of small model segments.
    Device Description
    The product is developed under the project name D 922. Flexitime bite is a scannable polyvinyl siloxane for bite registration with superior hardness and a very short application time in mouth. Its surface properties and optimised colour enable it to be optically recorded in CAD/CAM systems to portray the antagonists. Flexitime Bite can be scanned in the Heraeus scanner and many other CAD/CAM systems.
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    K Number
    K063062
    Device Name
    HKBOND 2006
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2006-12-01

    (57 days)

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

    HERAEUS KULZER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bonding of direct composite restorations (including Polyglas® and Compomer) . Bonding of indirect restoration in combination with a light-curing luting cement . Porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, rowns). Sealing hypersensitive areas of teeth. .
    Device Description
    Not Found
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    K Number
    K060994
    Device Name
    MONDIAL
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2006-05-22

    (41 days)

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

    HERAEUS KULZER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mondial line is synthetic polymer teeth for the fabrication of full and partial dentures. The enamel and dentine layers of HK teeth are highly cross-linked and suit the rate of natural abrasion. The base of the tooth is less cross-linked to achieve optimum bonding between the tooth and the denture acrylic.
    Device Description
    Mondial line is synthetic polymer teeth for the fabrication of full and partial dentures. The enamel and dentine layers of HK teeth are highly cross-linked and suit the rate of natural abrasion. The base of the tooth is less cross-linked to achieve optimum bonding between the tooth and the denture acrylic.
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    K Number
    K052543
    Device Name
    HERACERAM ZIRKONIA
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2005-10-25

    (40 days)

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

    HERAEUS KULZER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HeraCeram Zirkonia dental ceramic compound is intended for use with the rieraeona crown and bridge framework made of zirconia.
    Device Description
    Not Found
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    K Number
    K043504
    Device Name
    PALAIMPACT
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2005-01-28

    (39 days)

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

    HERAEUS KULZER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PalaImpact is a heat curing, high-impact denture acrylic resin for the fabrication of full and partial dentures. PalaImpact is also used for fixed and removable prosthetics devices.
    Device Description
    Not Found
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    K Number
    K043295
    Device Name
    VERSYO.DIRECT
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2005-01-05

    (37 days)

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

    HERAEUS KULZER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Versyo.direct is a light curing, methyl methacrylate free conditioner for the bonding of light curing prosthetic base materials to heat, self or light curing PMMA denture base materials and artificial teeth based on PMMA.
    Device Description
    Not Found
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    K Number
    K042878
    Device Name
    FLEXITIME XTREME
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2004-12-17

    (60 days)

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

    HERAEUS KULZER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flexitime Xtreme is a polyvinylsiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.
    Device Description
    Flexitime Xtreme is a polyvinylsiloxane silicone impression material.
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    K Number
    K030052
    Device Name
    OSTIM
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2004-12-06

    (700 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERAEUS KULZER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ostim is intended as a filling or reconstruction material for repair of bony defects in oral, gnathic and facial applications in the following indications: - Filling of intraoral bony defects such as those resulting from cytectomies, tooth tip I resections, extractions or surgical tooth removal. - Augmentations in the area of the alveolar processes and maxillary sinuses. - Filling of periodontal defects.
    Device Description
    Not Found
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    K Number
    K040859
    Device Name
    HERACERAM PRESS
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2004-05-20

    (48 days)

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

    HERAEUS KULZER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HeraCeram Press dental ceramic compound is intended for use with the veneering ceramic material HeraCeram. It can be used for full ceramic restorations with the common layering technique as well as the staining technique. Applications: Veneers, Inlays, Onlays and Crowns.
    Device Description
    Not Found
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