Not currently registered with FDA under this name
Ortho Technology, Inc.
Tampa, FL, United States. Named as applicant on 4 dental 510(k) clearances between 2000 and 2012. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42000–2012
- Markets registered in
- 545 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Ortho Technology, 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 | Ortho Technology, Inc. | 4 clearances | 2000–2012 | Below |
| Colombia | INVIMA | Manufacturer | ORTHOTECHNOLOGY INCORTHO TECHNOLOGY INC. | 27 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ORTHO TECHNOLOGY INC.ORTHO TECHNOLOGY, INC. · Ortho Technology, Inc. | 10 | 2006–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Ortho Technology, Inc. | 5 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Ortho Technology, Inc. | 3 | 2016–2018 | 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 Ortho Technology, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Jan 2012 | K112707 | GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM | NJM Orthodontic Ceramic Bracket |
| 18 Dec 2007 | K073045 | SAPPHIRE CERAMIC BRACKET | NJM Orthodontic Ceramic Bracket |
| 22 Jul 2005 | K051751 | EQUA-PULL SAFETY RELEASE MODULE | DZB Orthodontic Extraoral Headgear |
| 9 Jun 2000 | K000358 | MULTI ADJUSTABLE FACE MASK | DZB Orthodontic Extraoral Headgear |
Some of these clearances are listed with FDA today by another company: OSSTEM ORTHODONTICS Inc. (2), Ortho Organizers, Inc. (2), Five Star Orthodontic Laboratory & Supply, Inc. (1), American Orthodontics (1), Young Innovations Inc (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.