Not currently registered with FDA under this name
Villa Sistemi Medicali S.P.A.
Buccinasco, Italy. Named as applicant on 10 dental 510(k) clearances between 1999 and 2018. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 101999–2018
- Markets registered in
- 1075 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 10 markets
Where regulators' registries name Villa Sistemi Medicali S.P.A. 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 | Villa Sistemi Medicali S.P.A. | 10 clearances | 1999–2018 | Below |
| European Union | EUDAMED | Registration holder | Villa Sistemi Medicali S.p.A. | 21 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | VILLA SISTEMI MEDICALI S.P.A. | 20 | 2004–2013 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | VILLA SISTEMI MEDICALI S.P.AVILLA SISTEMI MEDICALI SPA · Villa Sistemi Medicali S.P.A | 9 | 2008–2018 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | VILLA SISTEMI MEDICALI S.P.A.VILLA SISTEMI MEDICALI SPA | 7 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Villa Sistemi Medicali SPAVilla Sistemi Medicali S.p.A. | 6 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Villa Sistemi Medicali S.p.aVILLA SISTEMI MEDICALI s.p.a · VILLA SISTEMI MEDICALI S.p.A | 6 | 2001–2007 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Villa Sistemi Medicali SpA | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | VILLA SISTEMI MEDICALI S.P.A.VILLA SISTEMI MEDICALI S.p.A. | 2 | 2013–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | VILLA SISTEMI MEDICALI S.P.A. | 1 | — | 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 Villa Sistemi Medicali S.P.A. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Nov 2018 | K180601 | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) | OAS Dental Computed Tomography X-Ray |
| 6 Jul 2017 | K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) | MUH Digital Extraoral Source X-Ray System |
| 1 Aug 2013 | K130109 | ENDOGRAPH DC | EHD Extraoral with Timer X-Ray Unit |
| 22 Jul 2011 | K111152 | ROTOGRAPH EVO 3D | MUH Digital Extraoral Source X-Ray System |
| 18 May 2009 | K090749 | ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 | EHD Extraoral with Timer X-Ray Unit |
| 21 Jul 2003 | K030634 | ENDOS DC | EHD Extraoral with Timer X-Ray Unit |
| 11 Mar 2003 | K030185 | ENDOS AC/ACP | EHD Extraoral with Timer X-Ray Unit |
| 1 Sep 2000 | K002432 | STRATO X | EHD Extraoral with Timer X-Ray Unit |
| 18 Jun 1999 | K991310 | EXPLOR-X 70 | EHD Extraoral with Timer X-Ray Unit |
| 14 Jan 1999 | K984524 | AZTECH 70 | EHD Extraoral with Timer X-Ray Unit |
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.