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510(k) Data Aggregation

    K Number
    K161281
    Device Name
    Dentalis Bio Solution Implants
    Date Cleared
    2017-01-11

    (250 days)

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

    DENTALIS BIO SOLUTION IMPLANTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dentalis Bio Solutions Implant System is used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The Dentalis Bio Solution implant with Narrow diameter Ø3.0 shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors situations. Dentalis Bio Solution One Piece implants are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. They are used for immediate, non-occlusal provisionalization in single-tooth restorations
    Device Description
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