BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS

    K Number: K080598 · Decision May 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    8
    Review Days
    79

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    Basic Information

    Device Name
    MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS
    K Number
    K080598
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intra-Lock International
    Date Received
    March 3, 2008
    Decision Date
    May 21, 2008
    Product Code
    NHA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NHA Abutment, Implant, Dental, Endosseous

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    Other Clearances by Intra-Lock International

    K Number Device Name
    K130140 INTRA-LOCK OP DENTAL IMPLANT
    K070601 MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM
    K050970 MILO DENTAL IMPLANT SYSTEM
    K040205 INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS
    K031322 INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS
    K021915 TRANSITIONAL IMPLANTS
    K021322 ENDOSSOUS IMPLANTS