BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CEFLA

    DI: 08033837938316 · Model: APEX LOCATOR · CEFLA SOCIETA' COOPERATIVA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CEFLA
    Primary DI
    08033837938316
    Version / Model
    APEX LOCATOR
    Catalog Number
    76000201
    Company Name
    CEFLA SOCIETA' COOPERATIVA
    Labeler DUNS
    429341410
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-31
    Public Version
    1
    Public Version Date
    2026-04-08
    Public Version Status
    New
    Public Device Record Key
    89dafb67-6f79-4040-82c1-463d109ac094

    Device Description

    APEX LOCATOR is a device intended for locating the apex of the root canal during endodontic treatments.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LQY Locator, Root Apex

    GMDN Terms

    Code Name
    16355 Endodontic apex locator

    Identifiers

    Type ID
    Primary 08033837938316

    Premarket Submissions

    Submission Number Supplement Number
    K231990 000

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    700 – 1060 millibar
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    30 – 75 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 70 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 100 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    500 – 1060 millibar