BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORABIO, INC.

    Reg #: 3030444281 · FEI: 3030444281 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORABIO, INC.
    Registration Number
    3030444281
    FEI Number
    3030444281
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    285 Kappa Dr Ste 100
    City
    Pittsburgh
    State
    PA
    ZIP
    15238
    Country
    US

    Regulatory Submissions

    510(k) Number
    K072306

    Owner / Operator

    Firm Name
    OraBio, Inc.
    Operator Number
    10089851
    Address
    285 Kappa Drive, Suite 100
    City
    Pittsburgh
    State
    PA
    Postal Code
    15238
    Country
    US
    Correspondent
    John Hauck

    Products

    Device Name Product Code
    Saliva, Artificial LFD

    Proprietary Names

    PERIOVANCE BIOXTRA

    Establishment Types

    Repack or Relabel Medical Device