BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD

    K Number: K895564 · Decision Nov 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    198
    Registration Numbers
    198
    Same Product Code
    24
    Applicant Total
    7
    Review Days
    61

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    Basic Information

    Device Name
    PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD
    K Number
    K895564
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6890
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Pemaco, Inc.
    Date Received
    September 6, 1989
    Decision Date
    November 6, 1989
    Product Code
    EGD
    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
    EGD Wax, Dental, Intraoral

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    Other Clearances by Pemaco, Inc.

    K Number Device Name
    K910676 INTRAORAL DENTAL WAX
    K895561 PEMACO 3000 INTRAORAL DENTAL WAX
    K895566 PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT
    K895562 PEMACO 2000 INTRAORAL DENTAL WAX
    K895563 PEMACO BITE WAX SHEETS
    K895565 PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD