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510(k) Data Aggregation

    K Number
    K080687
    Device Name
    SMARTBURS
    Manufacturer
    S.S. WHITE BURS, INC.
    Date Cleared
    2008-06-20

    (101 days)

    Product Code
    EJL
    Regulation Number
    872.3240
    Why did this record match?
    Product Code :

    EJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    After primary access using another instrument, Smartburs is intended to selectively remove decayed dentin, without removal of healthy dentin from tooth surfaces. Smartburs is not designed to cut or remove enamel, composite, amalgam, cementum, or healthy dentin.
    Device Description
    Smartburs
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    K Number
    K071352
    Device Name
    CERADRILL
    Manufacturer
    GEBR. BRASSELER GMBH & CO. KG
    Date Cleared
    2007-06-29

    (45 days)

    Product Code
    EJL
    Regulation Number
    872.3240
    Why did this record match?
    Product Code :

    EJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The drill is used to pre-drill into the maxilla or mandible to create an initial osteotomy for the later endosseous dental implant placement. The drills are used with a handpiece. CeraDrill is a ceramic drill for the dental implantology made of a modern high performance ceramic. The drills are intended to be used with a handpiece. The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement.
    Device Description
    CeraDrills within the new "CeraLine" is intended for use in implantology. These are made of high efficiency ceramics featuring an excellent cutting performance. The new CeraDrill offers the possibility of working without any metal, thus guaranteeing a biocompatible operation. Damages, as they occur in particular when disinfecting and cleaning steel burs with inappropriate agents, are now a thing of the past. The multifunctional ceramic drills are suited for initial preparation of the implant site axis and depth. The drills feature high initial sharpness and optimal cutting efficiency, thus achieving an effective material reduction. Due to their high efficiency toothing and the distinct tip-transversing blade, the drill has very good axial drilling properties for precise cutting without the need for prior use of a centering bur. The special twist drill blade geometry ensures smooth and precise operation. Moreover, the depth markings, which are lasered on to the working part in 2 mm intervals guarantee precise and safe control of the penetration depth. The CeraDrill family is available in diverse dimensions and shapes for the individual preparation on the osteotomy.
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    K Number
    K061383
    Device Name
    BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
    Manufacturer
    B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
    Date Cleared
    2006-08-03

    (77 days)

    Product Code
    EJL, NHA
    Regulation Number
    872.3240
    Why did this record match?
    Product Code :

    EJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental burs are intended to drill bone tissue and provisionally soft tissues during, before and after a surgical intervention of dental implants. Endosseous dental implant abutments are intended to model the gingival tissue during the process of healing after the first or second surgery and to be attached to the implant to hold single or multiple teeth restorations.
    Device Description
    Dental bur are rotary cutting devices intended to cut hard structures in the mouth, such as teeth or bone. They are also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices. Endosseous dental implant abutments are premanufactured prosthetic component directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation.
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