Not currently registered with FDA under this name
Orthodontic Design and Production, Inc.
Vista, CA, United States. Named as applicant on 2 dental 510(k) clearances between 2013 and 2013. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22013–2013
- Markets registered in
- 314 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Orthodontic Design and Production, Inc. 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 | Orthodontic Design and Production, Inc. | 2 clearances | 2013–2013 | Below |
| Colombia | INVIMA | Manufacturer | ORTHODONTIC DESIGN & PRODUCTION INC.ORTHODONTIC DESIGN AND PRODUCTION INC | 9 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ORTHODONTIC DESIGN & PRODUCTION, INC.ORTHODONTIC DESIGN AND PRODUCTION, INC | 5 | 2006–2011 | 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 Orthodontic Design and Production, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Dec 2013 | K132368 | VAPOR CERAMIC BRACKET | NJM Orthodontic Ceramic Bracket |
| 7 Jun 2013 | K130446 | FASTBRACES CERAMIC BRACKETS | NJM Orthodontic Ceramic Bracket |
Some of these clearances are listed with FDA today by another company: MPL Manufacturing Inc. (1), G&H Wire Company (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.