BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OraLabs, Inc.

    Reg #: 3001237145 · FEI: 3001237145 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    OraLabs, Inc.
    Registration Number
    3001237145
    FEI Number
    3001237145
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    18685 E Plaza Dr
    City
    Parker
    State
    CO
    ZIP
    80134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113326

    Owner / Operator

    Firm Name
    OraLabs, Inc.
    Operator Number
    10041724
    Address
    18685 East Plaza Drive
    City
    Parker
    State
    CO
    Postal Code
    80134
    Country
    US

    Products

    Device Name Product Code
    Mouthguard, Over-The-Counter OBR
    Saliva, Artificial LFD

    Proprietary Names

    Oral B Night Time Dental Guard Dry Mouth Spray

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device