BEUDAMED
    FDA Registration Active 🇨🇳 China

    TRIBEST DENTAL PRODUCTS CO LTD

    Reg #: 3008887731 · FEI: 3008887731 · Expires 2026
    View on FDA
    Products
    58
    Proprietary Names
    48
    Establishment Types
    4
    Classifications
    58

    Registration Details

    Registration Name
    TRIBEST DENTAL PRODUCTS CO LTD
    Registration Number
    3008887731
    FEI Number
    3008887731
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.98 Zhongling Road,Sanmao Street
    City
    Yangzhong Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K100854

    Owner / Operator

    Firm Name
    TRIBEST DENTAL PRODUCTS CO LTD
    Operator Number
    10035953
    Address
    No.5 Lianhe Cun,Xinba Town
    City
    Yangzhong
    State
    Jiangsu
    Postal Code
    212101
    Country
    CN
    Correspondent
    JIAHONG ZHOU

    US Agent

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

    Products

    Device Name Product Code
    Instrument, Contouring, Matrix, Operative EKF
    Cup, Prophylaxis EHK
    Non-Surgical Gown OEA
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Tray, Impression, Preformed EHY
    Gauze / Sponge,Nonresorbable For External Use NAB
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Frame, Spectacle HQZ
    Tray, Surgical, Instrument FSM
    Cotton, Roll EFN
    Tape And Bandage, Adhesive KGX
    Holder, Film, X-Ray EGZ
    Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) KOQ
    Magnifier, Hand-Held, Low-Vision HJF
    Forceps, Dressing, Dental EFL
    Unit, Operative Dental, Accessories NRD
    Wax, Dental, Intraoral EGD
    File, Pulp Canal, Endodontic EKS
    Floss, Dental JES
    Aligner, Bracket, Orthodontic ECQ
    Point, Paper, Endodontic EKN
    Syringe, Restorative And Impression Material EID
    Capsule, Dental, Amalgam DZS
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Mirror, Mouth EAX
    Blender/Mixer JRO
    Bur, Ear, Nose And Throat EQJ
    Evacuator, Oral Cavity EHZ
    Accessory, Surgical Apparel LYU
    Gutta-Percha EKM
    Chair, Examination And Treatment FRK
    Applicator, Resin KXR
    Toothbrush, Manual EFW
    Handle, Instrument, Dental EJB
    Band, Elastic, Orthodontic ECI
    Bur, Dental EJL
    Needle, Dental DZM
    Mask, Surgical FXX
    Instruments, Dental Hand DZN
    Aid, Transfer IKX
    Cleaner, Ultrasonic, Medical Instrument FLG
    Cap, Surgical FYF
    Mouthpiece, Saliva Ejector DYN
    Endoscopic Bite Block MNK
    Cleaner, Denture, Mechanical JER
    Mask, Scavenging KHA
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Wrap, Sterilization FRG
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Support, Patient Position CCX
    Absorber, Saliva, Paper KHR
    Probe, Periodontic EIX
    Bracket, Metal, Orthodontic EJF
    Applicator, Absorbent Tipped, Sterile KXG
    Cover, Shoe, Operating-Room FXP
    Instrument, Manual, Surgical, General Use MDM
    Bedding, Disposable, Medical KME
    Retractor, All Types EIG

    Proprietary Names

    Tofflemire matrix bands Dappen dish,glass,plastic Glass mortar & pestle Alcohol lamp No-stick mixing cup Dental Tray Plastic Tray Bite tray Mixing bowl & spatula, Cotton gauze, Mixing pad spatula Dental Occluding Paper, ALCOHOL PREP PAD, Dental tray paper cover Non-woven gauze, Mixing pad, Stirring rod Disposable dental syringe DISINFECTION CONTAINER (BOX) COTTON BALL Film positioning system complete Disposable dental kit, Disposable dental tweezer Disposable cups Universal barrier film dispenser Universal barrier film WAX,DENTAL,INTRAORAL ENDODONTIC PULP CANAL FILE Chewies ENDODONTIC FILE COMPOSITE GUN MIXING TIP Disposable dental mirror Plastic bur holder Air-water syringe tip (metal & plastic), Surgical tip Air-water syringe, tip cover, High volume evacuator GUTTA-PERCHA POINT,ABSORBENT PAPER POINTS MICRO BRUSH APPLICATOR Brush applicator with handle Micro applicator Dental Brush Brush applicator Polishing brush,Elastance chain,Ligature tie,Orthodontic Bracket,tooth model,Orthodontic kit Separator elastormeric,probe (forceps),Orthodontic elastic Orthodontic arch wire,Orthodontic band,Orthodontic buccal tube Dispensing tip Pre-bent needle tip RETAINER BOX,RETAINER CASE,DENTURE BOX Wrap,Sterilization pouch,Sterilization reel Disposable dental probe ORTHODONTIC KIT Cotton tipped applicator COVER, SHOE, OPERATING-ROOM Cotton roll dispenser Dental bib dispenser Face mask dispenser Denture box Retainer box Cheek retractor

    Establishment Types

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