BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    CAVEX HOLLAND B.V.

    Reg #: 9614573 · FEI: 3008898734 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    47
    Establishment Types
    4
    Classifications
    14

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    Registration Details

    Registration Name
    CAVEX HOLLAND B.V.
    Registration Number
    9614573
    FEI Number
    3008898734
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    FUSTWEG 5
    City
    HAARLEM Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K000686

    Owner / Operator

    Firm Name
    CAVEX HOLLAND B.V.
    Operator Number
    9033296
    Address
    FUSTWEG 5, --
    City
    HAARLEM
    State
    Noord-Holland
    Postal Code
    2031CJ
    Country
    NL
    Correspondent
    Milroy van der Bor

    US Agent

    Business Name
    Practicon
    Contact Name
    Brad Wilkinson
    Address
    1112 Sugg Parkway
    City
    Greenville
    State
    NC
    ZIP
    27834
    Country
    US
    Email
    [email protected]
    Phone
    252 7525183 ext. 5183

    Products

    Device Name Product Code
    Material, Impression ELW
    Cement, Dental EMA
    Heat Source For Bleaching Teeth EEG
    Disinfectant, Medical Devices LRJ
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Tray, Impression, Preformed EHY
    Agent, Tooth Bonding, Resin KLE
    Material, Tooth Shade, Resin EBF
    Plate, Base, Shellac EEA
    Toothbrush, Manual EFW
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Cleanser, Denture, Over The Counter EFT
    Wax, Dental, Intraoral EGD

    Proprietary Names

    Maxima Krom-Alginate Maxima Alginate Plus Cavex Temporary Cement Provisa Cem Emulate Cavex Bite&White ExSense White Royale Extreme Cleaning Toothpaste White Royale Perfection Whitening Pen Cavex Bite&White Cavex Bite&White StainLess Cavex ImpreSafe Cavex Instant Stone Cavex Bleach Transparant 1,0 mm Cavex Cream Alginate Quadrant Uni-1-Bond Cavex Impressional Cavex CA37 Quadrant Total Etch Quadrant Universal LC Quadrant Core LC Quadrant UniChem Quadrant Anterior Shine Quadrant Flow Quadrant Posterior Dense Cavex Dental Baseplate Cavex Individual Trays Cavex RushBrush Emulate Advanced Cavex Orthotrace Tulip Cavex CA 37 Kromalginate Xantalgin Select Cavex ColorChange Alginoplast Cavex SiliconA Tulip ColorSwitch Xantalgin Crono Alginate Plus Cavex StabiSil Simulate Vibringe MARK3 Evolution Cavex Prophy Paste Cavex GreenClean Emulate Colorchange Cavex SetUp

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device