Not currently registered with FDA under this name
Ortho Specialties
Gurnee, IL, United States. Named as applicant on 2 dental 510(k) clearances between 1994 and 2014. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 21994–2014
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Ortho Specialties as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Nov 2014 | K140807 | COMPOSITE ORTHODONTIC BRACKETS | DYW Orthodontic Plastic Bracket |
| 2 Feb 1994 | K936243 | REGENCY TUBE | DZD Orthodontic Tube |
Some of these clearances are listed with FDA today by another company: Xplora USA LLC (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.