# K111169: Protraction Face Mask, Reverse Pull Face Mask Model KM-PVS, KM-Pis, KM-PVM, KM-Pim, Model KM-FMS, KM-FML, KM-FMF

- Pathway: 510(k) (Traditional)
- Applicant: Kwang Myung Daicom, Inc.
- Decided: Oct 3, 2011 after 160 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
Protraction Face Mask and Reverse Pull Face Mask are used as a-treatment option for Class III malocclusions.

Source page: https://510kreport.com/device/K111169
Methodology: https://510kreport.com/methodology