BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Infinitas Orthodontic Mini Implant Sterile

    Reg #: 3004730002 · FEI: 3004730002 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    D B ORTHODONTICS LTD
    Registration Number
    3004730002
    FEI Number
    3004730002
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RYEFIELD WAY, SILSDEN, KEIGHLEY
    City
    WEST YORKSHIRE England
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K100633

    Owner / Operator

    Firm Name
    DB Orthodontics Limited
    Operator Number
    9065879
    Address
    Unit 6, Ryefield Way, Silsden
    City
    Keighley
    State
    GB-NOTA
    Postal Code
    BD20 0EF
    Country
    GB

    US Agent

    Business Name
    Rounding Third LLC dba Smile Stream Solutions
    Contact Name
    Tim Law
    Address
    Castle Rock, 1931 Liggett Rd Unit A16
    City
    Castle Rock
    State
    CO
    ZIP
    80109
    Country
    US
    Email
    [email protected]
    Phone
    888 2619933 ext. 100

    Products

    Device Name Product Code
    Implant, Endosseous, Orthodontic OAT

    Proprietary Names

    Infinitas Orthodontic Mini Implant Sterile

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Foreign Private Label Distributor Develop Specifications But Do Not Manufacture At This Facility