Cefla S.C.
Medical device manufacturer in Imola (Bo), IT.
21510(k) clearances
0PMA approvals
0recalls
Device types
- OAS X-Ray, Tomography, Computed, Dental 7
- MUH System, X-Ray, Extraoral Source, Digital 2
- EIA Unit, Operative Dental 2
- FLE Sterilizer, Steam 2
- JAK System, X-Ray, Tomography, Computed 2
- EBW Controller, Foot, Handpiece And Cord 2
- ELC Scaler, Ultrasonic 1
- EHD Unit, X-Ray, Extraoral With Timer 1
- LQY Locator, Root Apex 1
- LLZ System, Image Processing, Radiological 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260716 | NeowiseLLZ · Traditional | 05/04/2026SE |
| K252353 | myray ProXIma X6OAS · Traditional | 03/10/2026SE |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…EBW · Traditional | 04/01/2024SE |
| K231990 | Apex LocatorLQY · Traditional | 02/13/2024SE |
| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Special | 01/17/2023SE |
| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…EBW · Traditional | 05/09/2022SE |
| K220664 | NewTom 7GJAK · Traditional | 05/06/2022SE |
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Special | 01/20/2022SE |
| K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACTOAS · Traditional | 04/09/2020SE |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Traditional | 04/24/2019SE |
| K183448 | NewTom 5G XLJAK · Traditional | 03/08/2019SE |
| K161848 | Family of Steam sterilizers B17 B22 SeriesFLE · Traditional | 02/23/2017SE |
| K163519 | RX DCEHD · Traditional | 01/13/2017SE |
| K161900 | Hyperion X5OAS · Traditional | 12/09/2016SE |
| K151597 | Family of Steam Sterilizers B 28 seriesFLE · Traditional | 03/04/2016SE |
| K152162 | Myray- HYPERION X5MUH · Traditional | 12/24/2015SE |
| K133412 | S200, S300EIA · Traditional | 01/08/2015SE |
| K130834 | R7ELC · Traditional | 10/08/2013SE |
| K123381 | Hyperion X9OAS · Traditional | 05/10/2013SE |
| K092917 | Stern's S250 NordamEIA · Abbreviated | 06/24/2010SE |
| K081088 | Myray SkyviewMUH · Abbreviated | 11/06/2008SE |