BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    B.J.M. LABORATORIES LTD

    Reg #: 1000272892 · FEI: 1000272892 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    65
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    B.J.M. LABORATORIES LTD
    Registration Number
    1000272892
    FEI Number
    1000272892
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12 HASADNA ST., INDUSTRIAL PARK
    City
    OR-YEHUDA Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K260682

    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
    Varnish, Cavity LBH
    Agent, Tooth Bonding, Resin KLE
    Cement, Dental EMA
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Resin, Root Canal Filling KIF
    Sealant, Pit And Fissure, And Conditioner EBC
    Material, Tooth Shade, Resin EBF
    Cord, Retraction MVL

    Proprietary Names

    UNI-Q-Bond Universal Bonding Agent Bond-PR Universal Adhesive Premier Implant Cement Cem-Implant IDEAL 1 Band Cement Kit IDEAL 1 Bracket Adhesive System IDEAL 1 SE Primer STEP-1 PumEtch Resin Tooth Bonding Agent Obturys BJM Root Canal Sealer Activ GP Premier EndoCem Q-Glass Endo Enamel Loc QUICK SEAL Premier Self-Etching Enamel Sealant Q-SEAL Q-Match Universal Restorative Composite Premier's MultiMatch Universal Chameleon Restorative Composite NEOBOND HIGH-Q-BOND LINGUAL RETAINER HIGH-Q-BOND BRACKET PRIMER Q-ETCH ORTHO HIGH-Q-BOND BRACKET comprising PRIMER, LIGHT CURE ADHESIVE, ETCHANT HIGH-Q-BOND BAND CEMENT NEOBAND NEOBOND COMPULES HIGH-Q-BOND BRACKET LIGHT CURE ADHESIVE IN COMPULES HIGH-Q-BOND BRACKET ADHESIVE NEOBOND JR. KIT NEOBOND comprising GEL ETCH, PRIMER, PASTE SYRINGE Spot-On Etch Q-Etch Premier Etch MultiMatch Flow Chameleon AntiMicrobial Composite CompCore AF, Intro and Refill shades Q-CORE, Q-CORE Syringable IDEAL 1 Kit comprising Bracket Adhesive, Primer, Band Cement; Refills HIGH-Q-BOND PREMIER NEXTEMP TEMPORARY CEMENT Q-TEMP High-Q-Bond TotalCem DentoCem High-Q-Bond SE Biocoat Sealant PRIMA SE Primer BondBoost SE PRIMA Quick Prime ZIRCONITE HIQ-Q-BOND SE Q-CERAM Block-Out Resin IntegraBond Adhesive System, Bond 4ml and 7 ml, Activator and Etchant PERFECTA PRIMA 2000, PRIMA Quick, PRIMA SE, PRIMA 1, Auto-Cure Activator, Q-ETCH, Q-ETCH UF IntegraCem / Bond System, Base and Catalyst MULTIBOND PORCELAIN FIX comprising ETCH and SILANE Q-Ceram Premier Ceramic Primer TRAXODENT Zeramic Adhesive Resin Cement Zirconite Adhesive Resin Cement High-Q-Bond SE Adhesive Resin Cement

    Establishment Types

    Manufacture Medical Device