Morales Eco Protraction Face Mask

FDA UDI

Class II (US FDA UDI)

by Ortosim, S.A. de C.V.

Identity

Trade Name: Morales Eco Protraction Face Mask FDA UDI
Generic Name: Orthodontic extraoral headgear FDA UDI
Device Name: The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet. FDA UDI
Model / Reference: Eco FDA UDI
Description: The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet. FDA UDI

Identifiers

Primary DI / UDI-DI: D864ECO0 FDA UDI
510(k) Number: K032392 FDA UDI
FDA Product Code: DZB FDA UDI
GMDN Term: Orthodontic extraoral headgear FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic extraoral headgear

Morales Eco Protraction Face Mask by Ortosim, S.A. de C.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K032392 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ortosim, S.A. de C.V.

Sources (1)

FDA UDI bb01de96-1d01-4048-8ae4-dc32dd9f3dbf 34 fields · synced Jun 8, 2026