BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    PIEZOMED

    K Number: K133488 · Decision Oct 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    48
    Applicant Total
    18
    Review Days
    337

    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
    PIEZOMED
    K Number
    K133488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W&H Dentalwerk Buermoos GmbH
    Date Received
    November 13, 2013
    Decision Date
    October 16, 2014
    Product Code
    DZI
    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
    DZI Drill, Bone, Powered

    Similar 510(k) Clearances

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

    Implantmed Plus II & Piezomed Plus II Module

    FDA 510(k)
    FDA Class 2 ·Dental

    VarioSurg 4

    FDA 510(k)
    FDA Class 2 ·Dental

    MT-Bone

    FDA 510(k)
    FDA Class 2 ·Dental

    Surgical Drive System (Model: ES70, ES90, E8)

    FDA 510(k)
    FDA Class 2 ·Dental

    Guided Surgery Kit

    FDA 510(k)
    FDA Class 2 ·Dental

    TRAUS SUS20

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by W&H Dentalwerk Buermoos GmbH

    K Number Device Name
    K253776 Implantmed Plus II & Piezomed Plus II Module
    K243280 Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
    K201703 PROXEO Twist Cordless Polishing System PL-40 H
    K181858 Electric Handpiece Motor
    K171553 W&H Assistina Twin
    K143704 Advanced Air System
    K100600 PROSTHODONTIC SCREWDRIVER , MODEL IA-400
    K083811 W&H HANDPIECE ANESTO, MODEL: RA-5
    K090931 CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR
    K090548 CONTRA-ANGLE HANDPIECE KOMET OS30
    Search all 18 clearances from W&H Dentalwerk Buermoos GmbH →