BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    HIGH-Q-BOND

    Reg #: 1000272892 · FEI: 1000272892 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    B.J.M. LABORATORIES LTD
    Registration Number
    1000272892
    FEI Number
    1000272892
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12 HASADNA ST., INDUSTRIAL PARK
    City
    OR-YEHUDA Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K933766

    Owner / Operator

    Firm Name
    B.J.M. Laboratories Ltd
    Operator Number
    9057695
    Address
    12 Hasadna Street, Industrial Park
    City
    Or-Yehuda
    State
    Central
    Postal Code
    6022011
    Country
    IL
    Correspondent
    Barry N Zalsman

    US Agent

    Business Name
    Premier Dental Products Company
    Contact Name
    Jessica Huang
    Address
    1710 Romano Drive
    City
    Plymouth Meeting
    State
    PA
    ZIP
    19462
    Country
    US
    Email
    [email protected]
    Phone
    610 2396015 ext. 0

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    HIGH-Q-BOND IntegraCem / Bond System, Base and Catalyst Q-CERAM IntegraBond Adhesive System, Bond 4ml and 7 ml, Activator and Etchant Block-Out Resin PRIMA 2000, PRIMA Quick, PRIMA SE, PRIMA 1, Auto-Cure Activator, Q-ETCH, Q-ETCH UF HIQ-Q-BOND SE ZIRCONITE PERFECTA PORCELAIN FIX comprising ETCH and SILANE MULTIBOND

    Establishment Types

    Manufacture Medical Device