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

    HYDRO-CAST ACRYLIC VARNISH, MODEL 78125

    K Number: K991161 · Decision Apr 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    5
    Review Days
    22

    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
    HYDRO-CAST ACRYLIC VARNISH, MODEL 78125
    K Number
    K991161
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kay See Dental Mfg. Co.
    Date Received
    April 7, 1999
    Decision Date
    April 29, 1999
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

    Similar 510(k) Clearances

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

    Midmark Dental Delivery System

    FDA 510(k)
    FDA Class 1 ·Dental

    K5 Cart, K5 Mount, K5 Swing

    FDA 510(k)
    FDA Class 1 ·Dental

    Integral Dental Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    Integral Dental Units

    FDA 510(k)
    FDA Class 1 ·Dental

    Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

    FDA 510(k)
    FDA Class 1 ·Dental

    BDC Dental Unit

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

    Other Clearances by Kay See Dental Mfg. Co.

    K Number Device Name
    K001309 HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250
    K992609 HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400
    K990306 HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
    K990155 HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010