The following data is part of a premarket notification filed by Propel Orthodontics Llc with the FDA for Propel Device.
| Device ID | K172164 |
| 510k Number | K172164 |
| Device Name: | PROPEL Device |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | Propel Orthodontics LLC 394 South Abbott Ave Milpitas, CA 95035 |
| Contact | Bryce Way |
| Correspondent | Jeffrey Shapiro Propel Orthodontics LLC 700 Thirteenth Street, N.W. Washington, DC 20005 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-18 |
| Decision Date | 2018-01-17 |
| Summary: | summary |