BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DICOR CERAMIC INLAY - NEW TECHNIC

    K Number: K884166 · Decision Apr 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    279
    Review Days
    195

    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
    DICOR CERAMIC INLAY - NEW TECHNIC
    K Number
    K884166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dentsply Intl.
    Date Received
    October 4, 1988
    Decision Date
    April 17, 1989
    Product Code
    ELW
    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
    ELW Material, Impression

    Similar 510(k) Clearances

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

    Dia-X Sil Bite

    FDA 510(k)
    FDA Class 2 ·Dental

    Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);

    FDA 510(k)
    FDA Class 2 ·Dental

    JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

    FDA 510(k)
    FDA Class 2 ·Dental

    Elastic Impression Material

    FDA 510(k)
    FDA Class 2 ·Dental

    Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator

    FDA 510(k)
    FDA Class 2 ·Dental

    Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu

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

    Other Clearances by Dentsply Intl.

    K Number Device Name
    K123615 IRIS - HIGH STRENGTH GLASS CERAMIC
    K072730 FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
    K070538 XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
    K070019 CARRARA VOLUMIA
    K061427 PRE-IMPRESSION CONDITIONING SOLUTION
    K052334 CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
    K051707 ECLIPSE BONDING AGENT
    K051463 XENO ADHESIVE WITH ACTIVATOR
    K051462 MODIFICATION TO: CERCON BASE
    K050880 DYRACT EXTRA RESTORATIVE
    Search all 279 clearances from Dentsply Intl. →