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

    HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT

    K Number: K861846 · Decision Jun 26, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    15
    Applicant Total
    6
    Review Days
    44

    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
    HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT
    K Number
    K861846
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Solar Dental Co., Inc.
    Date Received
    May 13, 1986
    Decision Date
    June 26, 1986
    Product Code
    EIC
    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
    EIC Syringe, Periodontic, Endodontic, Irrigating

    Similar 510(k) Clearances

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

    RCT GEL ROOT CANAL THERAPY GEL

    FDA 510(k)
    FDA Class 1 ·Dental

    MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)

    FDA 510(k)
    FDA Class 1 ·Dental

    MAX-I-PROBE HANDPIECE

    FDA 510(k)
    FDA Class 1 ·Dental

    MAX-I-PROBE PERIODONTAL ENDODONTIC PROB

    FDA 510(k)
    FDA Class 1 ·Dental

    R & S SERIES FITTING TOOLS

    FDA 510(k)
    FDA Class 1 ·Dental

    WATER PISTOL

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

    Other Clearances by Solar Dental Co., Inc.

    K Number Device Name
    K871980 D-23 DENTURE ADHESIVE
    K852926 DENTOLOCK II DENTURE ADHESIVE CREAM
    K831294 SOLARCRY/TEMPORARY CROWN & BRIDGE MAT
    K831293 SOLARCRYL CUSTOM TRAY MATERIAL
    K831265 DENTOLOCK DENTURE ADHESIVE CREAM