# K032392: Morales Protraction Facemask

- Pathway: 510(k) (Traditional)
- Applicant: Ortosim, S.A. DE C.V.
- Decided: Oct 22, 2003 after 79 days
- Product code: DZB (Headgear, Extraoral, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K032392
Methodology: https://510kreport.com/methodology