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

    EJECTOR

    K Number: K924211 · Decision Mar 31, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    17
    Applicant Total
    8
    Review Days
    223

    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
    EJECTOR
    K Number
    K924211
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Glenroe Technologies
    Date Received
    August 20, 1992
    Decision Date
    March 31, 1993
    Product Code
    DYN
    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
    DYN Mouthpiece, Saliva Ejector

    Similar 510(k) Clearances

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

    DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR

    FDA 510(k)
    FDA Class 1 ·Dental

    SALIVA EJECTOR DISPOSABLE

    FDA 510(k)
    FDA Class 1 ·Dental

    HYGOFLEX SALIVA-EJECTOR

    FDA 510(k)
    FDA Class 1 ·Dental

    HIGH VAC

    FDA 510(k)
    FDA Class 1 ·Dental

    MINIDAM

    FDA 510(k)
    FDA Class 1 ·Dental

    SALIVA ABSORBER - DENTAL

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

    Other Clearances by Glenroe Technologies

    K Number Device Name
    K980053 GLENROE CHAIN
    K945535 GLENROE ORTHO-SIL
    K924351 GLENROE ELASTIBITE STIMULATOR
    K932920 GLENROE PLASTIC BRACKET
    K924140 TUFF TIES
    K924139 GLENROE ORTHO SEPS
    K924993 GLENROE BAND SEATING CONTOURING INSTRUMENT