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

    ACE HA SCREW DENTAL IMPLANT SYSTEM

    K Number: K021244 · Decision May 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    21
    Review Days
    14

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    Basic Information

    Device Name
    ACE HA SCREW DENTAL IMPLANT SYSTEM
    K Number
    K021244
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ace Surgical Supply Co., Inc.
    Date Received
    April 19, 2002
    Decision Date
    May 3, 2002
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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    Other Clearances by Ace Surgical Supply Co., Inc.

    K Number Device Name
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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
    K002075 ACE SDS 3.75MM SCREW DENTAL IMPLANT
    K990140 NORMED BONE TRANSPORT
    K981526 ACE ALVEOLAR DISTRACTOR
    Search all 21 clearances from Ace Surgical Supply Co., Inc. →