Not currently registered with FDA under this name
Castellini S.P.A.
Castel Maggiore, Bologna, Italy. Named as applicant on 4 dental 510(k) clearances between 1994 and 2003. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 41994–2003
- Markets registered in
- 335 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Castellini 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 | Castellini S.P.A. | 4 clearances | 1994–2003 | Below |
| Canada | Health Canada | Registration holder | CASTELLINI S.P.A. | 34 | 2005–2005 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CASTELLINI S.P.A. | 1 | 2012–2012 | 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 Castellini S.P.A. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 26 Mar 2003 | K023513 | LOGOS JUNIOR DENTAL CHAIR AND UNIT | EIA Operative Dental Unit |
| 14 Dec 2000 | K000834 | CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO | EFB Dental Air-Powered Handpiece |
| 11 Jul 2000 | K000837 | PUMA DENTAL CHAIR AND UNIT | EIA Operative Dental Unit |
| 25 Jan 1994 | K932111 | DENTAL X-RAY UNIT | 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.