BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ATOMO DENTAL, INC.

    Reg #: 3011279497 · FEI: 3011279497 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    30

    Registration Details

    Registration Name
    ATOMO DENTAL, INC.
    Registration Number
    3011279497
    FEI Number
    3011279497
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1241 Quarry Lane, Suite 125
    City
    Pleasanton
    State
    CA
    ZIP
    94566
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120970

    Owner / Operator

    Firm Name
    ATOMO Dental, Inc.
    Operator Number
    10047993
    Address
    1241 Quarry Lane, Suite 125
    City
    Pleasanton
    State
    CA
    Postal Code
    94566
    Country
    US
    Correspondent
    Tom Xu

    Products

    Device Name Product Code
    Toothbrush, Manual EFW
    Tray, Impression, Preformed EHY
    Non-Surgical Gown OEA
    Absorber, Saliva, Paper KHR
    Mask, Scavenging KHA
    Polymer Patient Examination Glove LZA
    Heat Source For Bleaching Teeth EEG
    Applicator, Resin KXR
    Cap, Surgical FYF
    Syringe, Restorative And Impression Material EID
    Camera, Television, Endoscopic, Without Audio FWF
    Loupe, Diagnostic/Surgical FSP
    Chair, Dental, Without Operative Unit NRU
    Disinfectant, Medical Devices LRJ
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Instrument, Filling, Plastic, Dental EIY
    Suit, Surgical FXO
    Wrap, Sterilization FRG
    Carver, Dental Amalgam, Operative EKH
    Cotton, Roll EFN
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Unit, Operative Dental, Accessories NRD
    Cleaner, Ultrasonic, Medical Instrument FLG
    Dispenser, Liquid Medication KYX
    Accessory, Surgical Apparel LYU
    Gauze / Sponge,Nonresorbable For External Use NAB
    Mouthpiece, Saliva Ejector DYN
    Unit, Syringe, Air And/Or Water ECB
    Floss, Dental JES
    Cup, Prophylaxis EHK

    Proprietary Names

    Toothbrush Dental Impression Tray, Bite Registration Tray, Disposable Impression Tray Isolation Gown, Isolation Jacket, Isolation Lab Coat Dental bib / apron Face mask Powder Free Nitrile Examination Gloves LED Whitening Light, LED Curing Light Micro Applicator; Valustick Sticky Applicator; Bendable brush applicator; composite brush and replaceable tip Bouffant Cap Dynamic HP Mixing Tips; Bent Needle Tips; Curved Utility Syringe; Dispensing Tips; Impression Gun; Intra-Oral Tips Intraoral Camera Dental Loupes ATOMO dental chair Hand Sanitizer gel, Alcohol Wipes PROPHY ANGLE baby tooth box; box; plastic dappen Coverall Surgical Suit Sterilization Pouch Disposable traps( filter); Plastic retainer/ denture; cuspidor strainer; amalgam carrier Cotton Roll Medical Goggles, model:MG-1 ATOMO air compressor and vacuum unit Dental Tray Cover, Headrest Cover, Intraoral Camera Sheath Barrier Film; Handpiece Sleeves; Instrument Tray Sleeves; Light/Sensor Sleeves/Pouches; Barrier Sleeves; Syringe Sleeves Ultrasonic Cleaner Polycoated Paper Cups; Plastic Cups Disposable Face Masks; KN95 Mask Non-woven Swab (Sponge); all-gauze sponges; Cotton Filled Exodontia Sponges Saliva ejector, Evacuator tips disposable dental Syringe, Air/Water Syringe tips Dental floss Prophy Angles; Prophy Brushes; Prophy Cups; Disposable Prophy Angles; Disposable Prophy Cups

    Establishment Types

    Repack or Relabel Medical Device