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

    SEAL RITE(TM)

    K Number: K902022 · Decision Jul 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    130
    Applicant Total
    78
    Review Days
    77

    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
    SEAL RITE(TM)
    K Number
    K902022
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3765
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Pulpdent Corp.
    Date Received
    May 4, 1990
    Decision Date
    July 20, 1990
    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 Pulpdent Corp.

    K Number Device Name
    K014133 PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
    K014138 PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
    K020115 PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
    K014059 PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
    K013411 PULPDENT CAVITY PREPARATION IV
    K994180 PULPDENT CAVITY PREPARATION III
    K994181 PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
    K994182 PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
    K993683 PULPDENT UNO-DUO
    K974202 PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
    Search all 78 clearances from Pulpdent Corp. →