Morales Mini Protraction Face Mask

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name: Morales Mini 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: Mini 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: D864MINI0 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 Mini Protraction Face Mask by Ortosim, S.A. de C.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic extraoral headgear.

3M™ — 3M UNITEK CORPORATION · Class II
3M™ — 3M UNITEK CORPORATION · Class II
ODP FACEMASK, REVERSE PULL — G&H Wire Company, Inc. · Class II
Multi-Adjustable Facemask — Ortho Organizers, Inc. · Class II
FACEMASK — Ortho Organizers, Inc. · Class II
ClassOne — Ortho Organizers, Inc. · Class II
G&H COLOR COATED FACEBOW — G&H Wire Company, Inc. · Class II
3M™ — 3M UNITEK CORPORATION · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

FDA UDI 44c36020-342c-4604-9c0e-18128fe84ddf 34 fields · synced Jun 8, 2026