Company ยท IT
Cefla S.C.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | 7 |
| EBW | Controller, Foot, Handpiece And Cord | 2 |
| EIA | Unit, Operative Dental | 2 |
| FLE | Sterilizer, Steam | 2 |
| JAK | System, X-Ray, Tomography, Computed | 2 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 |
| ELC | Scaler, Ultrasonic | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| LQY | Locator, Root Apex | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2026 | K260716 | Neowise Cefla S.C., IT | LLZ |
| Mar 10, 2026 | K252353 | myray ProXIma X6 Cefla S.C., IT | OAS |
| Apr 1, 2024 | K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, Cefla S.C., IT | EBW |
| Feb 13, 2024 | K231990 | Apex Locator Cefla S.C., IT | LQY |
| Jan 17, 2023 | K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS Cefla S.C., IT | OAS |
| May 9, 2022 | K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED Cefla S.C., IT | EBW |
| May 6, 2022 | K220664 | NewTom 7G Cefla S.C., IT | JAK |
| Jan 20, 2022 | K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS Cefla S.C., IT | OAS |
| Apr 9, 2020 | K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACT Cefla S.C., IT | OAS |
| Apr 24, 2019 | K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS Cefla S.C., IT | OAS |
| Mar 8, 2019 | K183448 | NewTom 5G XL Cefla S.C., IT | JAK |
| Feb 23, 2017 | K161848 | Family of Steam sterilizers B17 B22 Series Cefla S.C., IT | FLE |
| Jan 13, 2017 | K163519 | RX DC Cefla S.C., IT | EHD |
| Dec 9, 2016 | K161900 | HYPERION X5 Cefla S.C., IT | OAS |
| Mar 4, 2016 | K151597 | Family of Steam Sterilizers B 28 series Cefla S.C., IT | FLE |
| Dec 24, 2015 | K152162 | Myray- HYPERION X5 Cefla S.C., IT | MUH |
| Jan 8, 2015 | K133412 | S200, S300 Cefla S.C. | EIA |
| Oct 8, 2013 | K130834 | R7 Cefla S.C. | ELC |
| May 10, 2013 | K123381 | HYPERION X9 Cefla S.C. | OAS |
| Jun 24, 2010 | K092917 | STERN'S S250 NORDAM Cefla S.C. | EIA |
| Nov 6, 2008 | K081088 | MYRAY SKYVIEW Cefla S.C. | MUH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||