Not currently registered with FDA under this name
Propel Orthodontics, LLC
Milpitas, CA, United States. Named as applicant on 3 dental 510(k) clearances between 2015 and 2019. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32015–2019
- Markets registered in
- 623 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Propel Orthodontics, LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Propel Orthodontics, LLC | 3 clearances | 2015–2019 | Below |
| Canada | Health Canada | Registration holder | PROPEL ORTHODONTICS, LLC | 16 | 2014–2020 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PROPEL ORTHODONTICS, LLCPROPEL Orthodontics | 3 | 2019–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | PROPEL Orthodontics | 2 | 2016–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | Propel Orthodontics, LLC | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PROPEL ORTHODONTICS | 1 | 2014–2014 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Propel Orthodontics, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Nov 2019 | K183018 | VPro5 | OYH Orthodontic Vibratory Accessory |
| 17 Jan 2018 | K172164 | PROPEL Device | DZJ Manual Wire Driver and Bone Drill |
| 18 Sep 2015 | K150392 | PROPEL device | DZJ Manual Wire Driver and Bone Drill |
Some of these clearances are listed with FDA today by another company: Dentsply Sirona, Inc. (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.