BEUDAMED
    FDA Registration Active 🇨🇳 China

    HUBEI GUARDDENT MEDICAL TECHNOLOGY CO.,LTD

    Reg #: 3017910185 · FEI: 3017910185 · Expires 2026
    View on FDA
    Products
    51
    Proprietary Names
    51
    Establishment Types
    2
    Classifications
    51

    Registration Details

    Registration Name
    HUBEI GUARDDENT MEDICAL TECHNOLOGY CO.,LTD
    Registration Number
    3017910185
    FEI Number
    3017910185
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 24-29th, 2/F, No. 11 Block, No.1 Guiyuan Temple South Road, Hanyang District
    City
    Wuhan Hubei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K212718

    Owner / Operator

    Firm Name
    Hubei Guarddent Medical Technology Co.,Ltd
    Operator Number
    10078958
    Address
    Room 24-29th, 2/F, No. 11 Block, No.1 Guiyuan Temple South Road, Hanyang District
    City
    Wuhan City
    State
    Hubei
    Postal Code
    430070
    Country
    CN
    Correspondent
    Qin Hu

    US Agent

    Business Name
    ABMED MEDICAL TECHNOLOGY INC
    Contact Name
    Hui Hong
    Address
    800 E WISHKAH ST # 1021,ABERDEEN,WA,98520-2915, UNITED STATES
    City
    Aberdeen
    State
    WA
    ZIP
    98520
    Country
    US
    Email
    [email protected]
    Phone
    303 8000162

    Products

    Device Name Product Code
    Blade, Scalpel GES
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Syringe, Restorative And Impression Material EID
    Finger Cot LZB
    Instruments, Dental Hand DZN
    Bracket, Metal, Orthodontic EJF
    Protector, Dental BRW
    Floss, Dental JES
    Paper, Articulation EFH
    Depressor, Tongue, Non-Surgical FMA
    Point, Paper, Endodontic EKN
    Gown, Surgical FYA
    Mask, Surgical FXX
    Post, Root Canal ELR
    Gauze / Sponge,Nonresorbable For External Use NAB
    Non-Surgical Gown OEA
    Accessory, Surgical Apparel LYU
    Bedding, Disposable, Medical KME
    Evacuator, Oral Cavity EHZ
    Absorber, Saliva, Paper KHR
    Wax, Dental, Intraoral EGD
    Dam, Rubber EIE
    Wire, Orthodontic DZC
    Mouthpiece, Saliva Ejector DYN
    Dental Barriers And Sleeves PEM
    Chair, Examination And Treatment FRK
    Cup, Prophylaxis EHK
    Needle, Dental DZM
    Dispenser, Solid Medication NXB
    Tape And Bandage, Adhesive KGX
    Band, Elastic, Orthodontic ECI
    Retainer, Surgical GCZ
    Holder, Film, X-Ray EGZ
    File, Pulp Canal, Endodontic EKS
    Material, Impression Tray, Resin EBH
    Unit, Syringe, Air And/Or Water ECB
    Applicator, Resin KXR
    Accessories, Retractor, Dental EIF
    Tray, Surgical, Instrument FSM
    Cotton, Roll EFN
    Retractor, All Types EIG
    Mirror, Mouth EAX
    Cap, Surgical FYF
    Gutta-Percha EKM
    Cover, Shoe, Operating-Room FXP
    Retainer, Matrix JEP
    Toothbrush, Manual EFW
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Indicator, Physical/Chemical Sterilization Process JOJ
    Wrap, Sterilization FRG
    Bur, Dental EJL

    Proprietary Names

    Blade Pre Bent Needle Tips, Mixing Tips, irrigation syringe,dental needle lmpression Syringe Hygienic Finger Cots Gingival drainage Orthodontic Brackets Dental block Dental Floss Articulating Paper Tongue depressor Absorbent paper points surgical gowns face masks Fiber Post Nonwoven Gauze lsolation Gowns, Surgical Gown Face Shield disposable sheet High Volume HVE Tips Patient Bibs Dental Wax rubber dam Orthodontic Arch Wire Saliva Ejectors Dental Barrier and Sleeves Barrier covers, Barrier film Prophy angle/cup/brush Dental needle Barrier Film Dispenser, Cotton Rolls Dispenser Cohesive tape/self adhesive bandage wrap Orthodontic Rubber Chain and Ligature Tie Retainer Box,Denture box Phosphor Plate Endo file Impression Trays, Bite Registration Tray denture teeth Air Water Syringe Tips Micro Applicator Brush, Mixing Wells Mouth Prop Plastic Instrument Trays Cotton Rolls Cheek Retractor dental mouth mirror Bouffant Caps Gutta percha points Shoe Covers Matrix Bands Toothbrushes Cotton Applicators Self Sealing Sterilization Pouches dental Burs

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device