# K202855: Orthodontic Facemask

- Pathway: 510(k) (Traditional)
- Applicant: Ita.O Italian Orthodontic System S.R.L.
- Decided: Jun 21, 2021 after 266 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
Orthodontic Facemask is used as a treatment option for Class III malocclusions.

Source page: https://510kreport.com/device/K202855
Methodology: https://510kreport.com/methodology