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510(k) Data Aggregation

    K Number
    K141457
    Device Name
    DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS
    Manufacturer
    DENTIUM CO. LTD.
    Date Cleared
    2014-11-12

    (163 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTIUM CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.
    Device Description
    Dentium Implantium and SuperLine Abutments are intended for use an aid in prosthetic rehabilitation. The abutments were originally cleared under 510(k) k041358. The modified designs proposed in this submission consist of the Angled Screw Abutment, Cover Screw, and Screw Abutment Cylinders. Abutments are supplied non-sterile and autoclaved by the end user.
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