# K162543: Reverse Pull Adjustable Facemask

- Pathway: 510(k) (Traditional)
- Applicant: Sawbros Industries Pvt., Ltd.
- Decided: Aug 28, 2017 after 350 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
Longest line of descent: 1 generation back to K000358 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000358: Multi Adjustable Face Mask, Ortho Technology (2000) Summary page 5.

## Indications for use
Use as a treatment option for Class I1I malocclusion.

Source page: https://510kreport.com/device/K162543
Methodology: https://510kreport.com/methodology