BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HAGER WORLDWIDE, INC.

    Reg #: 1044031 · FEI: 1044031 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    88
    Establishment Types
    4
    Classifications
    37

    Registration Details

    Registration Name
    HAGER WORLDWIDE, INC.
    Registration Number
    1044031
    FEI Number
    1044031
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    441 19th St SE
    City
    Hickory
    State
    NC
    ZIP
    28602
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050658

    Owner / Operator

    Firm Name
    HAGER WORLDWIDE, INC.
    Operator Number
    3022877
    Address
    441 19th Street SE, --
    City
    Hickory
    State
    NC
    Postal Code
    28602
    Country
    US
    Correspondent
    Patrick Rouillard

    Products

    Device Name Product Code
    Disk, Abrasive EHJ
    Bur, Dental EJL
    Bath, Incubators/Water, All JTQ
    Light, Fiber Optic, Dental EAY
    Gauge, Depth, Instrument, Dental EIL
    Plaque Disclosing Agent QJC
    Unit, Operative Dental, Accessories NRD
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Cement, Dental EMA
    Unit, Syringe, Air And/Or Water ECB
    Floss, Dental JES
    Mouthpiece, Saliva Ejector DYN
    Anaerobic Box Glove JTM
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Frame, Rubber Dam EJE
    Instrument, Contouring, Matrix, Operative EKF
    Disinfectant, Medical Devices LRJ
    Forceps HTD
    Post, Root Canal ELR
    Cotton, Roll EFN
    Pin, Retentive And Splinting, And Accessory Instruments EBL
    Instruments, Dental Hand DZN
    Wax, Dental, Intraoral EGD
    Carver, Wax, Dental EIK
    Toothbrush, Manual EFW
    Scraper, Tongue LCN
    Cup, Prophylaxis EHK
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Tray, Surgical, Instrument FSM
    Evacuator, Oral Cavity EHZ
    Paper, Articulation EFH
    Remover, Crown EIS
    Container, Specimen, Non-Sterile NNI
    Material, Impression Tray, Resin EBH
    Holder, Film, X-Ray EGZ
    Accessories, Retractor, Dental EIF
    Tray, Impression, Preformed EHY

    Proprietary Names

    Almore Catalina Waerbath Quick-Detect Outback's Zoom Magnifiers Comfort Fit Magnifiers Felines Jewels Dream Shields Avions Reso Pac Duration Tip Uni-Tip Dura-Syringe Uni-Sryinge Access Tip Zahn Pick White SafeDispense Zahn Pick Soft + Comfi-Tips Surgical Tip Mirror Suction Double Sided Mirror Suction Mirasucto Bio Vacuum Tip Pelotte Vacuum Tip Sevdopter Swe-Flex Almore Anaerobic Jar Econo Tips Mirabrush Quick Tips Super Quick Tips Plast Frame Almore Microfil Composite Instruments Occlu-Spot Mylar Madam Butterfly Shimstock BioGuard Evacuation System Cleaner Dental Tweezers Mirapost Mirafit Quick Clip Almore Markley Wire Del-Ject Carrier, Tips, Spring, Piston Almore Bite Registration Wax and Tabs Almore Inlay Wax Almore Powdered Wax Almore Margin Wax Almore Soft Lining Trimmer Hager Wax Carving Set Almore Electra Waxer Almore Mini Waxer TS1 Tong-Clin Hager Prophy Angles Hager Prophy Brushes Rotoprox Comp-Blitz Almore Aluminum Oxide The Prepster BurButler Mirabor Bur-Tainor Bull Frog HVEs, Saliva Ejectors, and Accessories Mylar Foil Occlu-Plus TrollFoil Richwil MetaLift Crown Click DeLuxe Hager Wyman Crown Holder Almore Pressure Pot Almore Surfactant Miracast Salibag Soft Bitewing Flap Spandex Uni-Wedge Lip-Ex Spandex Advanced Mirahold Bite-Block Algilock Miratray Implant Advanced Miratray Adhesvie Spray Miracold Plus Spray

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility