Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035484470

FEI Number

3035484470

Entity Name

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

City/State/Country

Tijuana B.C. Baja California, MX

Establishment Address

Andador Arsenio Otanez 12502 Suite B Col. El Realito, Tijuana B.C. Baja California 22250, MX

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

K LINE EUROPE GMBH (Owner Number: 10079939)

Owner / Operator Contact Address

Bonner Strasse 203-393, SEGRO Park Dusseldorf-Sud, Section 203 K, Dusseldorf-Benrath, DE-NW 40589, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

K Clear CLEAR X

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2021-01-05

Official Correspondent

Sherif Kandil

US Agent Details

Chris Brown Email: acliviconsulting@gmail.com Phone: (810) 3609773

Related Public Records

Same Entity

K LINE EUROPE GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3044853366	K Line Egypt	Cairo, EG
3033492726	K Line Portugal Unipessoal Ltd	Chaves Braga, PT
3044462786	K Line Florida	West Palm Beach, FL, US

Similar Registrations

Registration Number	Establishment Name	Location
3042902614	MYT USA CORP	Chino, CA, US
3032027578	Solventum Orthodontics Corporation	Monrovia, CA, US
3009955691	HANGZHOU DTC MEDICAL APPARATUS CO., LTD	Hangzhou Zhejiang, CN
3033492726	K Line Portugal Unipessoal Ltd	Chaves Braga, PT
8043622	RICHBOLT ENTERPRISES	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035484470. Last updated year: 2026. Please use registration number 3035484470 when referencing this establishment in official correspondence.