Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011788941

FEI Number

3011788941

Entity Name

ORTOTEC DE BC MX SA DE CV

City/State/Country

Tecate Baja California, MX

Establishment Address

Benito Juarez No. 751, Tecate Baja California 21440, MX

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

MPL MANUFACTURING INC (Owner Number: 10054003)

Owner / Operator Contact Address

451 Tecate Rd, Tecate, CA 91980, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Metal Bracket

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2021-01-04
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2018-08-27
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2017-05-25
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2023-04-11

Official Correspondent

Mario Perez

US Agent Details

Mario Perez Business: MPL MANUFACTURING INC Email: mperez@ortotec.mx Phone: (619) 8203337

Related Public Records

Same Entity

MPL MANUFACTURING INC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027157163	ORTOMPL SA DE CV	Tecate Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

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3032163716	Solventum US LLC	Irvine, CA, US
3032027578	Solventum Orthodontics Corporation	Monrovia, CA, US
1054415	CDB CORPORATION	Leland, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011788941. Last updated year: 2026. Please use registration number 3011788941 when referencing this establishment in official correspondence.