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510(k) Data Aggregation

    K Number
    K153753
    Device Name
    TelioCAD Multi
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2016-04-12

    (105 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR VIVADENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For manufacturing by a CAD/CAM System: - Provisional anterior and posterior crowns with a maximum wear period of up to 12 months - Provisional anterior and posterior bridges with up to two adjacent pontics for a maximum wear period of up to 12 months - Provisional inlay and onlays
    Device Description
    Telio CAD Multi are PMMA discs used for fabrication of long-term temporaries by means of CAD/CAM technology. The PMMA discs have a Long-term (12-month) wear period and durable shade stability with lifelike layered appearance. The device is available in 8 shades (BL2, A1, A2, A3, A3.5, A4, B1 and B2) and 4 thicknesses 12mm, 16mm, 20mm and 25mm. They are the standard 98.5 mm in diameter to permit use with the Wieland Select Milling equipment or other equipment which accepts 98.5 mm discs. The material exhibits high homogeneity due to industrial manufacturing process and temporaries can be easily reproduced using the CAD/CAM Technology. The device is contraindicated for use in permanent restorations and bridge designs involving more than two adjacent pontics. The device should not be used in patients with para-functional habits, ex. Bruxism or patients known to be allergic to the ingredients.
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    K Number
    K143575
    Device Name
    Accu-Dent XD Tray, Accu-Dent XD Syringe
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2015-04-03

    (107 days)

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

    IVOCLAR VIVADENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accu-Dent XD impression materials are recommended for used to create highly detailed impressions of the hard and soft tissues of the oral cavity includin the following list of indications: - Complete and partial denture impressions ● - Opposing models for fixed and removable prosthesis ● - o Study Model - Temporary crown & Bridge impressions - Whitening Trays ● - Mouth Guards ● - Orthodontic Impressions o
    Device Description
    Accu-Dent XD is a two-part Alginate impression system intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide impressions models for study and for production of restorative prosthetic devices, such as full and partial dentures.
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    K Number
    K132984
    Device Name
    SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2014-01-14

    (112 days)

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

    IVOCLAR VIVADENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
    Device Description
    Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
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    K Number
    K111958
    Device Name
    TETRIC EVOCERAM BULK FILL
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2011-10-14

    (95 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR VIVADENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Restoration of Deciduous teeth Restorations in the posterior region (Classes I and ii) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Extended fissure sealing in molars and premolars
    Device Description
    Not Found
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    K Number
    K110756
    Device Name
    BLUEPHASE STYLE
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2011-08-29

    (164 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR VIVADENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For light curing polymerization of light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting mateirals for brackets and indirect restorations, such as ceramic inlays.
    Device Description
    Not Found
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    K Number
    K103556
    Device Name
    IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2011-04-13

    (132 days)

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

    IVOCLAR VIVADENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPS e.max® CAD Crystall/Connect and IPS e.max® CAD Crystall/Add-On Connect (for CAD-On Technique) is intended to be used for the fabrication of: Crowns Splinted crowns 3-4 unit bridges Crown, splinted crown or 3-4 unit bridge placed on top of an implant abutment ._
    Device Description
    Not Found
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    K Number
    K103528
    Device Name
    IPS EMPRESS DIRECT FLOW
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2011-02-25

    (87 days)

    Product Code
    EBF, EBC, EBD
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR VIVADENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As an intermediate or covering layer in the fabrication of esthetically demanding composite restorations Repair of composite restorations (in particular filling of voids, levelling out of porosities and minor chips) As a thin (< 0.5mm) initial layer under Class I and II restorations Small restorations of all types Extended fissure sealing Splinting of mobile teeth Blocking out of undercuts Repair of composite and ceramic veneers
    Device Description
    Not Found
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    K Number
    K103391
    Device Name
    IVOBASE HYBRID, IVOBASE HIGH IMPACT
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2011-02-17

    (90 days)

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

    IVOCLAR VIVADENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IvoBase Hybrid and IvoBase High Impact are intended for the fabrication of PMMA based acrylic dental prosthesis including but not limited to partial and full dentures.
    Device Description
    Not Found
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    K Number
    K103379
    Device Name
    TELIO CS INLAY & TELIO CS ONLAY
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2011-02-14

    (89 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR VIVADENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Telio CS Inlay: Temporization of deep inlay preparations with paralle! walls Sealing of implant screw access holes Relining of pre-fabricated, temporary crowns and bridges made of polycarbonate or methacrylates. Telio CS Onlay: Temporization of large, shallow cavities (onlay preparations).
    Device Description
    Not Found
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    K Number
    K093708
    Device Name
    TELIO CAD
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2010-03-10

    (98 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR VIVADENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the fabrication of temporary crowns and bridges using the CAD/CAM technology until the permanent restoration can be delivered.
    Device Description
    Not Found
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