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

    APEX ELECTRIC HANDPIECE SYSTEM

    K Number: K031540 · Decision Jun 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    8
    Review Days
    45

    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
    APEX ELECTRIC HANDPIECE SYSTEM
    K Number
    K031540
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lares Research, Inc.
    Date Received
    May 16, 2003
    Decision Date
    June 30, 2003
    Product Code
    EKX
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EKX Handpiece, Direct Drive, Ac-Powered

    Similar 510(k) Clearances

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

    Alpha Endo Handpiece (Alpha Endo)

    FDA 510(k)
    FDA Class 1 ·Dental

    InnerView System

    FDA 510(k)
    FDA Class 1 ·Dental

    EnDrive (EnDriveUS)

    FDA 510(k)
    FDA Class 1 ·Dental

    Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

    FDA 510(k)
    FDA Class 1 ·Dental

    ChecQ (AC100)

    FDA 510(k)
    FDA Class 1 ·Dental

    HPR Cordless Hygiene Handpiece

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

    Other Clearances by Lares Research, Inc.

    K Number Device Name
    K141221 LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR
    K011960 LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)
    K983524 LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)
    K961163 LARES RESEARCH AS-1 LOWSPEED HANDPIECE
    K905543 LARES APOLLO CS/CP/C
    K905542 LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS
    K905541 LARES 757 WORKHORSE HIGHSPEED HANDPIECE