BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rannix - ceramic bracket with Metal slot system Roth slot 18

    Reg #: 3013410675 · FEI: 3013410675 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ortho Pro Dent LLC
    Registration Number
    3013410675
    FEI Number
    3013410675
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1903 Northgate Blvd,Northogate Executive Center, suite 114
    City
    Sarasota
    State
    FL
    ZIP
    34234
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090567

    Owner / Operator

    Firm Name
    Ortho Pro Dent LLC
    Operator Number
    10053964
    Address
    1903 Northgate Blvd , Northgate Executive center, suite 114
    City
    Sarasota
    State
    FL
    Postal Code
    34234
    Country
    US
    Correspondent
    EDWARD ELIAS

    Products

    Device Name Product Code
    Bracket, Ceramic, Orthodontic NJM

    Proprietary Names

    Rannix - ceramic bracket with Metal slot system Roth slot 18 Rannix - ceramic bracket with Metal slot system MBT slot 22 Glace- Crystal Sapphire Bracket System MBT slot 22 Rannix - ceramic bracket with Metal slot system Roth slot 22 Rannix - ceramic bracket with Metal slot system MBT slot 18 Orthodontic ceramic bracket with metal slot Translex - ceramic bracket system Roth slot 18 Glace- Crystal Sapphire Bracket System MBT slot 18 Translex - ceramic bracket system Roth slot 22 Translex - ceramic bracket system MBT slot 18 Glace- Crystal Sapphire Bracket System Roth slot 18 Orthodontic Mono Crystalline Sapphire Bracket Translex - ceramic bracket system MBT slot 22 Orthodontic ceramic bracket. Glace- Crystal Sapphire Bracket System Roth slot 22

    Establishment Types

    Repack or Relabel Medical Device