Not currently registered with FDA under this name
Flexmedics
Minnetonka, MN, United States. Named as applicant on 10 dental 510(k) clearances between 1986 and 1994. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 101986–1994
- Markets registered in
- 731 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 7 markets
Where regulators' registries name Flexmedics 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 | Flexmedics | 10 clearances | 1986–1994 | Below |
| United Kingdom | MHRA | Manufacturer | FlexMedics Inc. | 18 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Flexmedics | 3 | 2009–2009 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | FLEXMEDICS | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Flexmedics | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | FlexMedics CorporationFLEXMEDICS CORPORATION | 3 | 1999–1999 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Flexmedics | 1 | 2026–2026 | 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 Flexmedics as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Jan 1994 | K934265 | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE | DZC Orthodontic Wire |
| 10 Jan 1989 | K885086 | TIN COATED NITI ORTHODONTIC ARCH WIRES | EJF Orthodontic Metal Bracket |
| 14 Nov 1988 | K883120 | FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE | EJF Orthodontic Metal Bracket |
| 21 Apr 1988 | K881331 | ORTHODONTIC NITINOL SPRINGS | EJW Wire Clasp |
| 12 Apr 1988 | K881274 | CENTER BEND ARCH WIRES | EJF Orthodontic Metal Bracket |
| 12 Apr 1988 | K881233 | STRAIGHT LENGTH ARCH WIRES | EJF Orthodontic Metal Bracket |
| 11 Apr 1988 | K880882 | REVERSE CURVE ARCHWIRE | EJF Orthodontic Metal Bracket |
| 7 Apr 1988 | K881163 | RECTANGULAR NITINOL ARCH WIRE | EJF Orthodontic Metal Bracket |
| 5 Oct 1987 | K873649 | FLEX GOLD | EJF Orthodontic Metal Bracket |
| 24 Nov 1986 | K863742 | FLEXMEDICS NITINOL ARCH WIRE | DZC Orthodontic Wire |
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.