Manufacturer registered with FDA

Fernando Morales Garfias

TLALNEPANTLA, EDO.DE MEX., Mexico. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9052068Contract manufacturerManufacturer

Device types listed: 1
Brands and models: 3
510(k) clearances: 12003–2003
Markets registered in: 21 registrations outside the US
Establishments: 1Mexico

510(k) clearances per year, 2000–2026

Registered in 2 markets

Where regulators' registries name Fernando Morales Garfias as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: MexicoOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Fernando Morales Garfias	1 clearances	2003–2003	Below
Costa Rica	Ministerio de Salud	Manufacturer	Ortosim S.A. de C.V.	1	—	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Fernando Morales Garfias currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Orthodontic Extraoral HeadgearDZB · Class 2	Retainers, expanders & headgear	Maker	AD Protraction FacemaskAsian Profile AD Protraction FacemaskMORALES PROTRACTION FACEMASK	2010

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Fernando Morales Garfias as the applicant, including filings under its other names.

Decided	510(k)	Device	Device type
22 Oct 2003	K032392	MORALES PROTRACTION FACEMASK	DZB Orthodontic Extraoral Headgear

Registered establishments

Establishment	Location	What it does
ORTOSIM, S.A. DE C.V.FDA reg. 3003948427	TLALNEPANTLA Mexico, Mexico	Contract manufacturer, Manufacturer

Other names on FDA records

Ortosim S.A. de C.V.

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9052068). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.