BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Border Assembly S. de R.L de C.V.

    Reg #: 3023401336 · FEI: 3023401336 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    Border Assembly S. de R.L de C.V.
    Registration Number
    3023401336
    FEI Number
    3023401336
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Andador Arsenio Otanez 12502 Col. El Realito
    City
    Tijuana Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K190948

    Owner / Operator

    Firm Name
    Candid Care Co.
    Operator Number
    10055632
    Address
    1200 Chamber Road, Suite 307
    City
    Columbus
    State
    OH
    Postal Code
    43212
    Country
    US
    Correspondent
    Jim Churchill

    US Agent

    Business Name
    Candid Care Co.
    Contact Name
    Jon Cook
    Address
    1200 Chambers Road, Suite 307
    City
    Columbus
    State
    OH
    ZIP
    43212
    Country
    US
    Email
    [email protected]
    Phone
    408 5333081

    Products

    Device Name Product Code
    Aligner, Sequential NXC
    Material, Impression ELW
    Oral Irrigation Kit OGT
    Maintainer, Space Preformed, Orthodontic DYT
    Retractor, All Types EIG

    Proprietary Names

    Candid Aligner FGS-3002 Oliv Aligner Kit FGS-3008 Oliv Refinement Kit Candid Aligner Kit FGS-0001, FGS-0002; Candid Care Replacement Kit FGS-0004; Candid Care Refinement Kit FGS-0008 FGS-3004 Oliv Replacement Kit FGS-2002 Glidewell Aligner Kit FGS-2004 Glidewell Replacement Kit FGS-2008 Glidewell Refinement Kit ProMonitoring Aligner Kit Kettenbach Impression Kt ZOOM! Whitening Procedure Kit Candid Care Retainer PermaForm Retainer Candid Care Retainer Kit FGS-0003 FGS-3003 PermaForm Retainer Oliv FGS-2003 PermaForm Retainer Glidewell FGS-0003 PermaForm Retainer Candid Cheek Retractor ScanBox Pro

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device