Not currently registered with FDA under this name

Cefla S.C. Cefla Dental Group

Imola, Italy. Named as applicant on 1 dental 510(k) clearance between 2012 and 2012. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12012–2012
Markets registered in
21 registrations outside the US
Establishments
0—
2012: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Cefla S.C. Cefla Dental Group as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesSaudi Arabia: 1 registrations
RegisteredHome: ItalyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantCefla S.C. Cefla Dental Group1 clearances2012–2012Below
Saudi ArabiaSFDAManufacturerCefla s.c. – Cefla Dental Group1—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. Cefla Dental Group as the applicant.

Decided510(k)DeviceDevice type
17 Jan 2012K113497HYPERIONMUH Digital Extraoral Source X-Ray System

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.