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510(k) Data Aggregation

    K Number
    K171197
    Device Name
    Zuga Dental Implant System
    Manufacturer
    Date Cleared
    2018-06-30

    (432 days)

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

    Zuga Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, healing caps, dental implant abutments, and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one-or two-stage procedures. Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is blasted, then passivated. Sizematched anterior and posterior abutments are offered. Thes are fastened to the implant using a fixation screw. Sealing caps and healing caps provide protection to the abutment connection threads during endosseous and gingival healing. The implants are provided sterile, the remaining components must be sterilized prior to use.
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    K Number
    K122664
    Device Name
    ZUGA DENTAL IMPLANT SYSTEM
    Manufacturer
    Date Cleared
    2013-04-30

    (242 days)

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

    ZUGA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Zuga-Dental-Implant-System-is-indicated-for-immediate-or-delayed-implant-placement-forsurgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures. The Zuga Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading
    Device Description
    The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, gum shapers, dental implant abutments and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one- or two-stage procedures. Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is aluminum oxide (Al2O3) blasted then passivated. These are offered in diameters from 3.5 to 5.5mm in diameter with lengths ranging from 8mm to 17mm. Sizematched anterior and posterior abutments are offered having post heights from 4.0 to 7.0mm. These are fastened to the implant using a fixation screw. Sealing caps and gum shapers provide protection to the abutment connection threads during endosseous and gingival healing. The implants are provided sterile, the remaining components must be sterilized prior to use.
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