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

    SALIVA EJECTOR

    K Number: K861934 · Decision Jun 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    20

    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
    SALIVA EJECTOR
    K Number
    K861934
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Carlisle Laboratories, Inc.
    Date Received
    May 20, 1986
    Decision Date
    June 9, 1986
    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

    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
    View all

    Other Clearances by Carlisle Laboratories, Inc.

    K Number Device Name
    K861685 SUPERLON (UNILON) CARBOXYLATE CEMENT