Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003678542

FEI Number

3003678542

Entity Name

CALIBAJA MANUFACTURING, S.A. DE C.V.

City/State/Country

MEXICALI Baja California, MX

Establishment Address

Calle Circuito Siglo XXI No. 1990,, Modulo A y B, Parque Industrial Siglo XXI,, MEXICALI Baja California C.P. 21254, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CALIBAJA MANUFACTURING, S.A. DE C.V. (Owner Number: 9049944)

Owner / Operator Contact Address

Calle Circuito Siglo XXI No. 1990,, Modulo A y B, Parque Industrial Siglo XXI,, MEXICALI, MX-BCN 21254, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

311xlc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2002-03-01
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2002-03-01
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2025-06-26
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2007-12-31
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2015-08-04
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2002-03-01
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2016-11-28
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2016-11-28

Official Correspondent

Travis Rose

US Agent Details

Travis Rose Business: CaliBaja Manufacturing Email: travis.rose@calibaja.com Phone: (760) 5626449

Related Public Records

Same Entity

CALIBAJA MANUFACTURING, S.A. DE C.V.

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

View Entity Profile →

Related 510(k) Records

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

Similar Registrations

Registration Number	Establishment Name	Location
3010462491	DW Lingual Systems GmbH	Bad Essen Lower Saxony, DE
3009257060	Ortho Traction Pads	Norwalk, CT, US
3027343382	UNIVY TECHNOLOGY ADVANCED CO. LTD	Shanghai, CN
3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
3012232878	SUNSTAR TRADING INTERNATIONAL LIMITED	Kowloon Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003678542. Last updated year: 2026. Please use registration number 3003678542 when referencing this establishment in official correspondence.