Not currently registered with FDA under this name
Classone Orthodontics, Inc.
Lubbock, TX, United States. Named as applicant on 3 dental 510(k) clearances between 2006 and 2010. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32006–2010
- Markets registered in
- 411 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name Classone Orthodontics, 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 | Classone Orthodontics, Inc. | 3 clearances | 2006–2010 | Below |
| South Korea | MFDS | Manufacturer | CLASS ONE ORTHODONTICS | 5 | 2004–2005 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | CLASS ONE ORTHODONTICS, INC | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CLASS ONE ORTHODONTICSCLASSONE ORTHODONTICS | 2 | 2006–2012 | 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 Classone Orthodontics, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Feb 2010 | K093059 | SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 16 Jul 2008 | K080445 | LION SE ONE STEP ORTHODONTIC ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 25 Jan 2006 | K053379 | RELI-ON ONE STEP, ORTHODONTIC ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
Some of these clearances are listed with FDA today by another company: Five Star Orthodontic Laboratory & Supply, Inc. (2).
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.