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510(k) Data Aggregation

    K Number
    K101225
    Device Name
    PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1
    Manufacturer
    PROMIMIC AB
    Date Cleared
    2011-01-25

    (267 days)

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

    PROMIMIC AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Promimic AB, Promimic Dental Implant is intended for surgical placement into the bone of upper/ lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function. The Promimic Dental Implant can be immediately loaded only with good primary stability and appropriate occlusal loading. The Promimic Dental Implants are only to be used with straight abutments.
    Device Description
    The Promimic Dental Implant consists of 4 implants, diameter 3.75 mm, and length from 8.5 to 15.0 mm.
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