Not currently registered with FDA under this name
Cefla S.C.R.L.
Ormond Beach, FL, United States. Named as applicant on 3 dental 510(k) clearances between 2006 and 2008. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32006–2008
- Markets registered in
- 26 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Cefla S.C.R.L. 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 | Cefla S.C.R.L. | 3 clearances | 2006–2008 | Below |
| South Korea | MFDS | Manufacturer | CEFLA S.C.R.L.Cefla s.c.r.l · CEFLA S.C.R.L | 6 | 2002–2004 | 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 Cefla S.C.R.L. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Mar 2008 | K080076 | RX DC X-RAY UNIT | EHD Extraoral with Timer X-Ray Unit |
| 14 Dec 2006 | K062897 | C-U2 | EIA Operative Dental Unit |
| 6 Jun 2006 | K061114 | WDS, SIZE 2 AND SIZE 2 | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: Cefla S.C. (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.