BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇷 Greece

    DMP PIT & FISSURE SEALANT

    K Number: K102252 · Decision Dec 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    130
    Applicant Total
    6
    Review Days
    115

    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
    DMP PIT & FISSURE SEALANT
    K Number
    K102252
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3765
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dmp, Ltd.
    Date Received
    August 10, 2010
    Decision Date
    December 3, 2010
    Product Code
    EBC
    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
    EBC Sealant, Pit And Fissure, And Conditioner

    Similar 510(k) Clearances

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

    Any-Com Seal

    FDA 510(k)
    FDA Class 2 ·Dental

    Parkell Pit and Fissure Sealant

    FDA 510(k)
    FDA Class 2 ·Dental

    UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio

    FDA 510(k)
    FDA Class 2 ·Dental

    Enamel Coating Resin

    FDA 510(k)
    FDA Class 2 ·Dental

    BA Pit & Fissure Sealant

    FDA 510(k)
    FDA Class 2 ·Dental

    Helioseal F Plus

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

    Other Clearances by Dmp, Ltd.

    K Number Device Name
    K121915 BRIGHT RESTORATIVE MATERIALS
    K102836 BONASIL A+ IMPRESSION MATERIALS
    K102254 DMP SINGLE BONDING
    K102255 DMP ETCHING GEL
    K102257 NANOCERAM- BRIGHT