Not currently registered with FDA under this name
Cefla Dental Group
North Attleboro, MA, United States. Named as applicant on 2 dental 510(k) clearances between 2010 and 2010. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22010–2010
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Cefla Dental Group 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 Dental Group | 2 clearances | 2010–2010 | Below |
| South Korea | MFDS | Manufacturer | CEFLA DENTAL GROUP | 1 | 2011–2011 | 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 Dental Group as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Oct 2010 | K100960 | WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS | MUH Digital Extraoral Source X-Ray System |
| 16 Sep 2010 | K101661 | MYRAY HYPERION | 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.