BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    PUMA DENTAL CHAIR AND UNIT

    K Number: K000837 · Decision Jul 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    4
    Review Days
    120

    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
    PUMA DENTAL CHAIR AND UNIT
    K Number
    K000837
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Castellini S.P.A.
    Date Received
    March 13, 2000
    Decision Date
    July 11, 2000
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

    Similar 510(k) Clearances

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

    Midmark Dental Delivery System

    FDA 510(k)
    FDA Class 1 ·Dental

    K5 Cart, K5 Mount, K5 Swing

    FDA 510(k)
    FDA Class 1 ·Dental

    Integral Dental Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    Integral Dental Units

    FDA 510(k)
    FDA Class 1 ·Dental

    Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

    FDA 510(k)
    FDA Class 1 ·Dental

    BDC Dental Unit

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

    Other Clearances by Castellini S.P.A.

    K Number Device Name
    K023513 LOGOS JUNIOR DENTAL CHAIR AND UNIT
    K000834 CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO
    K932111 DENTAL X-RAY UNIT