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

    ACE BONE SCREW TACKING KIT

    K Number: K951510 · Decision Aug 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    79
    Applicant Total
    21
    Review Days
    144

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    Basic Information

    Device Name
    ACE BONE SCREW TACKING KIT
    K Number
    K951510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4880
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ace Surgical Supply Co., Inc.
    Date Received
    April 3, 1995
    Decision Date
    August 25, 1995
    Product Code
    DZL
    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
    DZL Screw, Fixation, Intraosseous

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    Other Clearances by Ace Surgical Supply Co., Inc.

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    K073343 ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX
    K080074 ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
    K061397 ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
    K051381 ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
    K041759 ACE CONNECT INTERNAL CONNECTION
    K021244 ACE HA SCREW DENTAL IMPLANT SYSTEM
    K002075 ACE SDS 3.75MM SCREW DENTAL IMPLANT
    K990140 NORMED BONE TRANSPORT
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