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

    IPT CAPSULE MIXER

    K Number: K922203 · Decision Jun 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    23

    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
    IPT CAPSULE MIXER
    K Number
    K922203
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3100
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ipt Technologies, Inc.
    Date Received
    May 11, 1992
    Decision Date
    June 3, 1992
    Product Code
    EFD
    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
    EFD Amalgamator, Dental, Ac-Powered

    Similar 510(k) Clearances

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

    PENTAMIX 2

    FDA 510(k)
    FDA Class 1 ·Dental

    SILIMAT PLUS

    FDA 510(k)
    FDA Class 1 ·Dental

    AUTOMIX DENTAL AMALGAMATOR

    FDA 510(k)
    FDA Class 1 ·Dental

    DUOMAT 3 AMALGAMATOR

    FDA 510(k)
    FDA Class 1 ·Dental

    MIXOMAT AMALGAMATOR

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTOMAT 3 AMALGAMATORS

    FDA 510(k)
    FDA Class 1 ·Dental
    View all