Not currently registered with FDA under this name
Dyna Flex
Lake Saint Louis, MO, United States. Named as applicant on 4 dental 510(k) clearances between 2011 and 2023. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42011–2023
- Markets registered in
- 737 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Dyna Flex 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 | Dyna Flex | 4 clearances | 2011–2023 | Below |
| South Korea | MFDS | Manufacturer | DynaFlexDyna Flex · Dynaflex · +1 | 18 | 2009–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DYNA FLEX | 6 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DYNA FLEX | 6 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DYNAFLEXDYNA FLEX | 4 | 2015–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DYNAFLEXDYNAFLEX CO. | 2 | 2011–2021 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DYNAFLEX LTD. | 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 Dyna Flex as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 Jun 2023 | K230225 | DynaFlex Clear Brackets & Buttons | NJM Orthodontic Ceramic Bracket |
| 27 Jun 2019 | K190583 | DynaFlex | NXC Sequential Aligner |
| 14 Aug 2012 | K121396 | DYNAFLEX | NXC Sequential Aligner |
| 23 Feb 2011 | K103076 | DYNAFLEX | LRK Anti-Snoring Device |
Some of these clearances are listed with FDA today by another company: Ortho Solutions LC (3).
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.