BEUDAMED
    FDA Registration Active 🇨🇳 China

    JIANGXI DENTALBRIGHT TECHNOLOGY CO., LTD

    Reg #: 3012041047 · FEI: 3012041047 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    40
    Establishment Types
    3
    Classifications
    19

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    Registration Details

    Registration Name
    JIANGXI DENTALBRIGHT TECHNOLOGY CO., LTD
    Registration Number
    3012041047
    FEI Number
    3012041047
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Makou industrial park, Yongxiu County
    City
    Jiujiang City Jiangxi
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K211489

    Owner / Operator

    Firm Name
    Jiangxi Dentalbright Technology Co., Ltd
    Operator Number
    10052165
    Address
    Makou industrial park, Yongxiu County
    City
    Jiujiang City
    State
    Jiangxi
    Postal Code
    330300
    Country
    CN
    Correspondent
    Justin Qin

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Syringe, Restorative And Impression Material EID
    Toothbrush, Manual EFW
    Material, Impression ELW
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Accessory, Surgical Apparel LYU
    Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium KOT
    Floss, Dental JES
    Heat Source For Bleaching Teeth EEG
    Cleanser, Denture, Over The Counter EFT
    Toothbrush, Powered JEQ
    Eraser, Dental Stain MAU
    Mouthpiece, Breathing BYP
    Dam, Rubber EIE
    Dilator, Nasal LWF
    Retractor, All Types EIG
    Unit, Oral Irrigation EFS
    Adaptor, Hygiene ILS
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Tray, Impression, Preformed EHY

    Proprietary Names

    dental impression material Teeth Wipes, Brush Ups, Finger Brush, Oral Brush Ups, Bamboo toothbrush, Plastic toothbrush, toothbrush, bamboo toothbrush, Travel Kit Toothbrush & Toothpaste tablets/(refill) Dental Impression Material Plastic Glasses Isolation Mask; Face Mask denture adhesive cream; denture adhesive powder Dental Floss Plusma Light; Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light; ProLite LED Teeth Whitening Device, Wireless Dental Instrument Teeth Whitening Mini Light; Mini Light 1led/5led;Teeth Whitening Light 8led/16led; Smart Teeth Whitening Device; Smart Teeth Whitening Light; Teeth Whitening Lamp; Teeth Whitening Accelerator; Teeth whitening Led Light 8led/16led; Teeth Whitening Mouth Tray Led Light; Teeth Whitening Mouth Tray Light Denture Cleansing Tablet, Aligner Cleaner Electric Toothbrush, Sonic Toothbrush, Electric Led Toothbrush, Sonic Led Toothbrush Teeth Whitening Pen/Bleaching Pen/Teeth Whitener/Teeth Whitening Gel 3ml/5ml/10ml/PROFESSIONAL WHITENING GEL Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel Teeth Bleaching System/Teeth Bleaching Kit/Teeth Whitening Strips/Double Elastic Gel Strips/Dry Strips teeth whitening powder, Stain Prevention, Preventive Whitening Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit/Teeth Whitening System; charcoal teeth whitening powder,coconut oil pulling;coconut oil sachet, BE LUCENT Teeth Whitening Pen Dissolving Strips teeth whitening foam tripsPearlSmile Teeth Whitening Kit; Charcoal Teeth Whitening Strips SAYCHEESE Teeth Whitening Kit Teeth Whitening Essence Xquisite Smile Teeth Whitening Kit V34 Colour Corrector; V34 Colour Corrector Foam; NHpro Enamel Care; HA5 Hyaluronic Serum Immune Support Serum; Serum Duo Oral Spray; Teeth Whitening Led Kit; Bleachy Teeth Whitening kit; Bleachy Teeth Whitening Led Kit BE LUCENT NHpro Enamel Care; BE LUCENT HA5 Gum Serum Anti Snore Mouth Piece/Snoring Stopper/Anti Snore Mouth Tray/Stop Snoring Solution/Anti Snore Kit/Stop Snoring Device Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel Stop Snoring Chin Strap/Anti Snore Jaw Supporter/Stop Snoring Solution/Anti Snore Belt/Chin Strap Belt Cheek Retractor/Mouth Opener/Lip Retractor, Silicone Cheek Retractor Oral irrigator Disinfectant box for denture, Toothbrush sterilization box Vitamin E Swab, Bent Tips Thermoplastic Mouth Tray/Mouth Piece/Teeth Whitening Mouth Tray/Foam Strip Mouth Tray/Gel Prefilled Mouth Tray Teeth Protector/ Mouth Guard

    Establishment Types

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