Medical Device Manufacturer · IT , Imola (Bo)

Cefla S.C. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2008

Total

Cleared

Denied

Cefla S.C., is a diversified industrial group based in Imola, Italy. The company operates through multiple business units, including a dedicated Medical Equipment division that develops dental and diagnostic imaging devices.

Cefla has maintained a strong FDA 510(k) regulatory record since 2008. The company has received 20 FDA 510(k) clearances from 20 total submissions, with no denied submissions. Its cleared devices span radiology and dental categories, including cone beam computed tomography (CBCT) systems, dental micromotors, and apex locators. The latest clearance was granted in 2026, confirming active regulatory engagement.

Cefla's Medical Equipment business supports clinical workflows across diagnostic imaging, dental treatment, sterilization systems, and diagnostic software. The company is known for innovations in CBCT technology and precision dental instrumentation, serving healthcare providers globally.

Explore the full list of cleared device names, product codes, and clearance dates in the database.

FDA 510(k) Regulatory Record - Cefla S.C.

20 devices

1-12 of 20