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

    INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS

    K Number: K040205 · Decision Mar 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    8
    Review Days
    52

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS
    K Number
    K040205
    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
    January 30, 2004
    Decision Date
    March 22, 2004
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NHA), ordered by most recent decision date.

    Neodent Scannable Healing Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)

    FDA 510(k)
    FDA Class 2 ·Dental

    DESS Dental Smart Solutions

    FDA 510(k)
    FDA Class 2 ·Dental

    SIC Abutments including CAD/CAM Solutions

    FDA 510(k)
    FDA Class 2 ·Dental

    Elos Accurate® Denture Fixation System

    FDA 510(k)
    FDA Class 2 ·Dental

    ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Intra-Lock International

    K Number Device Name
    K130140 INTRA-LOCK OP DENTAL IMPLANT
    K080598 MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS
    K070601 MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM
    K050970 MILO DENTAL IMPLANT SYSTEM
    K031322 INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS
    K021915 TRANSITIONAL IMPLANTS
    K021322 ENDOSSOUS IMPLANTS