Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007513373

FEI Number

3007513373

Entity Name

E. TEC SA DE C.V.

City/State/Country

Tijuana Baja California, MX

Establishment Address

Calle Colegio Militar #900, Colonia Tomas Auino, Tijuana Baja California 22240, MX

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Universal Orthodontic Lab, Inc. (Owner Number: 10025859)

Owner / Operator Contact Address

11917 Front Street, Norwalk, CA 90650, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Operative Contouring Matrix Instrument Preformed Orthodontic Band Pliers RETAINER, MOUTHGUARD, BITEGUARD Orthodontic Tube Dental Wax Saliva Ejector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKF	Instrument, Contouring, Matrix, Operative	Dental	Class 1	872.4565	2013-11-08
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2008-05-29
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2013-11-08
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2013-11-08
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2008-05-30
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2013-11-08
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2013-11-11
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2013-11-08

Official Correspondent

No official correspondent registered.

US Agent Details

CUONG TRAN Business: ALYSTA CORPORATION Email: cuong.tran@alystacorp.com Phone: (714) 6350453

Related Public Records

Same Entity

Universal Orthodontic Lab, 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
3007010296	Universal Orthodontic Lab, Inc.	Norwalk, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

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3003963832	PDT, INC.	MSLA, MT, US
3008887731	TRIBEST DENTAL PRODUCTS CO LTD	Yangzhong Jiangsu, CN
3020650140	GREATER CURVE	Cincinnati, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007513373. Last updated year: 2026. Please use registration number 3007513373 when referencing this establishment in official correspondence.