BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES

    K Number: K040671 · Decision Dec 14, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    44
    Applicant Total
    10
    Review Days
    274

    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
    EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES
    K Number
    K040671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anthogyr
    Date Received
    March 15, 2004
    Decision Date
    December 14, 2004
    Product Code
    EJI
    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
    EJI Syringe, Cartridge

    Similar 510(k) Clearances

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

    LeEject 2 Dental Syringe and Needle System

    FDA 510(k)
    FDA Class 2 ·Dental

    Miltex N-Tralig Intraligamentary Syringe

    FDA 510(k)
    FDA Class 2 ·Dental

    HU-FRIEDY DENTAL CARTRIDGE SYRINGE

    FDA 510(k)
    FDA Class 2 ·Dental

    ANESTHESIA INJECTION TOOL SET

    FDA 510(k)
    FDA Class 2 ·Dental

    MORPHEUS

    FDA 510(k)
    FDA Class 2 ·Dental

    ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE

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

    Other Clearances by Anthogyr

    K Number Device Name
    K231072 Anthogyr FlexiBase® titanium bases for Axiom® BL
    K233264 Anthogyr INTEGRAL Guided Surgery Cassettes
    K230104 Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
    K230680 Anthogyr Surgical Cassettes
    K160730 Instrument kits
    K093894 ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
    K090676 MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
    K041279 IMPLANTEO IMPLANTOLOGY MOTOR
    K040674 IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES