Not currently registered with FDA under this name
Midwest Orthodontic Mfg.
Columbus, IN, United States. Named as applicant on 7 dental 510(k) clearances between 1990 and 1998. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 71990–1998
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Midwest Orthodontic Mfg. 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 | Midwest Orthodontic Mfg. | 7 clearances | 1990–1998 | Below |
| South Korea | MFDS | Manufacturer | Midwest Orthodontic Mfg. | 1 | 2000–2000 | 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 Midwest Orthodontic Mfg. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 25 Jun 1998 | K981433 | ORTHODONTIC BRACES | DYW Orthodontic Plastic Bracket |
| 8 Feb 1996 | K955740 | GLUFLORMA | KLE Resin Tooth Bonding Agent |
| 12 Sep 1995 | K952856 | LIGHT-CURE PC | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 8 Sep 1995 | K952855 | PC-LOCK | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 5 Sep 1995 | K952858 | LIGHT-CURE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 5 Sep 1995 | K952857 | PRO-LOCK | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 22 May 1990 | K900824 | FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) | EJF Orthodontic Metal Bracket |
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.