Not currently registered with FDA under this name
Owandy
Ormond Beach, FL, United States. Named as applicant on 7 dental 510(k) clearances between 2006 and 2014. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 72006–2014
- Markets registered in
- 418 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name Owandy 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 | Owandy | 7 clearances | 2006–2014 | Below |
| Canada | Health Canada | Registration holder | OWANDY | 14 | 2006–2013 | Pure Global AI |
| Australia | TGA | Manufacturer | Owandy | 2 | 2004–2006 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Owandy | 2 | 2007–2012 | 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 Owandy as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Apr 2014 | K133271 | OPTEO, VIDEOGRAPH HD | MUH Digital Extraoral Source X-Ray System |
| 14 Jun 2013 | K130443 | I-MAX TOUCH 3D | OAS Dental Computed Tomography X-Ray |
| 18 Oct 2010 | K093105 | VISTEO | EHD Extraoral with Timer X-Ray Unit |
| 2 Jun 2009 | K083057 | I-MAX TOUCH | MUH Digital Extraoral Source X-Ray System |
| 5 Apr 2007 | K070505 | KRYSTAL-X WIFI | MUH Digital Extraoral Source X-Ray System |
| 14 Nov 2006 | K062403 | IMAX CEPH DIGITAL X-RAY SENSOR | MUH Digital Extraoral Source X-Ray System |
| 9 Jun 2006 | K053172 | UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: De Götzen S.R.L. (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.