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510(k) Data Aggregation

    K Number
    K201412
    Device Name
    BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit
    Manufacturer
    BEGO Implant Systems GmbH & Co. KG
    Date Cleared
    2021-02-18

    (266 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BEGO Implant Systems GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMA-DOS® PKTr 58357 are intended to store and organize the BEGO Semados® surgical instruments, insertion tools, drill stops and prosthetic instruments during both steam sterilization in an autoclave and implant/ prosthetic treatments. BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMA-DOS® PKTr 58357 are not intended on its own to maintain sterility; it is intended to be used with a legally marketed, validated, FDA-cleared sterilization pouch.
    Device Description
    BEGO SEMADOS® Tr 58350 is composed of three main components: a tray cover, a tray container and a tray insert, all made of polyphenylsulfone. The tray container and the tray insert have additional silicone rubber grommets to store and organize the BEGO Semados® surgical instruments and insertion tools. The tray container and tray insert are printed to indicate the surgical workflow and the position of the above mentioned instruments within the tray for reprocessing and implant/ prosthetic treatments. BEGO SEMADOS® Tr 58350 is supplied without BEGO Semados® surgical instruments and insertion tools. BEGO SEMADOS® RS/RSX-LINE TRAY PLUS is supplied as a kit with BEGO SEMADOS® Tr 58350 and BEGO Semados® surgical instruments and insertion tools. BEGO Semados® Tr 58349 is composed of three main components: a tray cover, a tray container and a tray insert, all made of polyphenylsulfone. The tray container and the tray insert have additional silicone rubber grommets to store and organize the BEGO Semados® surgical instruments and insertion tools. The tray container and tray insert are printed to indicate the surgical workflow and the position of the above mentioned instruments within the tray for reprocessing and implant/ prosthetic treatments. BEGO Semados® Tr 58349 is supplied without BEGO Semados® surgical instruments and insertion tools. BEGO Semados® Tr 58348 is supplied as a kit with BEGO Semados® Tr 58349 and BEGO Semados® surgical instruments and insertion tools. BEGO Semados® DSTr 58356 is composed of two main components: a tray cover made of polyphenylsulfone and a tray container made of polypropylene. The tray container has inserts to store and organize the drill stops. The tray container is printed to indicate the position of the drill stops within the tray for reprocessing and implant treatments. BEGO Semados® DSTr 58356 is supplied without drill stops. DRILL STOP TRAY PLUS (RS/RSX-Line) is supplied as a kit with BEGO Semados® DSTr 58356 and drill stops. BEGO SEMADOS® PKTr 58357 is composed of two main components: a tray cover made of polyphenylsulfone and a tray container made of polypropylene. The tray container has inserts to store and organize the BEGO Semados® insertion tools and prosthetic instruments. The tray container is printed to indicate the position of the above mentioned instruments within the tray for reprocessing and implant/prosthetic treatments. BEGO SEMADOS® PKTr 58357 is supplied without BEGO Semados® insertion tools and prosthetic instruments. PROSTHETIC KIT is supplied as a kit with BEGO SEMADOS® PKTr 58357 and BEGO Semados® insertion tools and prosthetic instruments.
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    K Number
    K201700
    Device Name
    BEGO Semados® RS/RSX Implant System
    Manufacturer
    BEGO Implant Systems GmbH & Co. KG
    Date Cleared
    2021-01-13

    (205 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BEGO Implant Systems GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BEGO Semados® RS/RSX implant is indicated for single or multiple unit restorations on splinted or non-splinted applications both in the upper and lower jaw. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading on sufficient primary stability and appropriate occlusal loading. The BEGO Semados® RS/RSX implant 3.0 is only indicated for single unit restorations of the lower lateral, central incisors or upper lateral incisors. The healing posts are indicated for patients treated with BEGO Semados® RS/RSX implants for the time during healing of the surrounding soft tissue. The abutments are indicated for patients treated with BEGO Semados® RS/RSX implants as an aid in prosthetic rehabilitation. PS ITA, PS TTiA and PS TTiA NH are intended to be used for a maximum period of 6 months.
    Device Description
    The BEGO Semados® RS/RSX Implant System consists of implants, healing posts and abutments. BEGO Semados® RS/RSX implants are self-tapping, conical endosseous dental implants made of commercially pure titanium Grade 4. In contrast to the RSX implant family, the RS implant family has a 0.5 mm machined neck region. BEGO Semados® RS/RSX implants are marketed together with cover screws and insertion posts. The healing posts are sterile packaged Titanium Grade 5 dental healing abutments that are available in two different sizes. Healing posts can be used either to shape the soft tissue after sub-merged healing of an implant (two-stage) or to keep the shape of the soft tissue after having placed the implant (one-stage). The abutments are prefabricated prosthetic components made of Titanium Grade 5 directly connected to BEGO Semados® implants with Platform Switch design such as BEGO Semados® RS/RSX implants. They are delivered non-sterile but have to be sterilized by the end-user. They serve as an aid in temporary (provisional) and permanent prosthetic rehabilitation. The abutments are used for single or multiple tooth restorations. There are two types of abutments regarding the duration of use: provisional abutments intended for a limited period of ≤ six months and permanent abutments. The abutments are marketed with the compatible prosthesis and a technician screw. The MultiPlus system consists of the PS MultiPlus abutments, the MultiPlus Titanium abutment, the MultiPlus Healing posts, the MULTI PLUS UNIVERSAL component and various supporting tools. The MultiPlus system is intended for occlusal screw-retained bridge, full dentures and bar constructions in the mandible and maxilla. The Easy-Con system consists of the PS Easy-Con abutment and the Easy-Con laboratory set. The Easy-Con system is used to retain full supported dentures in the mandible or maxilla on two to four implants.
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    K Number
    K090716
    Device Name
    BEGO SEMADOS S-LINE
    Manufacturer
    BEGO IMPLANT SYSTEMS GMBH & CO. KG
    Date Cleared
    2009-10-06

    (202 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BEGO IMPLANT SYSTEMS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bego Semados® S-line threaded endosseous dental implants are indicated for restorations in the upper and lower jaw (single tooth replacement, abutments for bridgework, partial or complete edentolism)
    Device Description
    BEGO Semados® S-Line with TiPure"155 Surface is a dental implant system that can be placed subgingivally in both the upper and lower jaw using a one- or two-stage surgical procedure.
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