Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003948427

FEI Number

3003948427

Entity Name

ORTOSIM, S.A. DE C.V.

City/State/Country

TLALNEPANTLA Mexico, MX

Establishment Address

CONVENTO DE ACTOPAN No. 13-A, TLALNEPANTLA Mexico 54050, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FERNANDO MORALES GARFIAS (Owner Number: 9052068)

Owner / Operator Contact Address

CONVENTO DE ACTOPAN #13-A, --, TLALNEPANTLA, EDO.DE MEX., MX-NOTA 54050, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K032392

PMA Number

N/A

All Registered Proprietary Names

MORALES PROTRACTION FACEMASK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2010-05-06

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

FERNANDO MORALES GARFIAS

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003948427. Last updated year: 2026. Please use registration number 3003948427 when referencing this establishment in official correspondence.