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

    DISCOID/CLEOID DOUBLE END AMALGAM CARVER

    K Number: K901177 · Decision Apr 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    71
    Applicant Total
    11
    Review Days
    34

    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
    DISCOID/CLEOID DOUBLE END AMALGAM CARVER
    K Number
    K901177
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    American Medical Ceramics, Inc.
    Date Received
    March 13, 1990
    Decision Date
    April 16, 1990
    Product Code
    EKJ
    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
    EKJ Burnisher, Operative

    Similar 510(k) Clearances

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

    ASEPTYLUM, UNI-CARRIER

    FDA 510(k)
    FDA Class 1 ·Dental

    MEDTROL DENTAL KIT

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTAL KIT

    FDA 510(k)
    FDA Class 1 ·Dental

    SUREFLEX FILES

    FDA 510(k)
    FDA Class 1 ·Dental

    INSTRUMENT,FILLING,PLASTIC,DENTAL

    FDA 510(k)
    FDA Class 1 ·Dental

    STAT PAK

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

    Other Clearances by American Medical Ceramics, Inc.

    K Number Device Name
    K901178 AMALGAM CONDENSER
    K901172 GRACEY CURETTE #13-14
    K901170 PERIODONTAL KNIFE
    K901175 HAND MIRROR
    K901173 DISCOID SPOON EXCAVATOR
    K901174 ELEVATOR #11
    K901176 #23 EXPLORER
    K901169 5 STRAIGHT SCISSORS
    K901171 U-15 SINGLE END SCALER
    K896843 EXPLORER 24 DENTAL HAND INSTRUMENT
    Search all 11 clearances from American Medical Ceramics, Inc. →