# K172164: PROPEL Device

- Pathway: 510(k) (Traditional)
- Applicant: Propel Orthodontics, LLC
- Decided: Jan 17, 2018 after 183 days
- Product code: DZJ (Driver, Wire, And Bone Drill, Manual)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K082649 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150392: PROPEL device, Propel Orthodontics, LLC (2015) Summary page 4.

## Indications for use
The PROPEL Device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including: (1) initiation holes for drill bits, implants, screws, plates, and other orthodontic appliances; and (2) for use as a tool to create micro-osteoperforations.

Source page: https://510kreport.com/device/K172164
Methodology: https://510kreport.com/methodology