FDA 510(k) Applications Submitted by CEFLA S.C.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K081088 |
04/16/2008 |
MYRAY SKYVIEW |
CEFLA S.C. |
| K092917 |
09/22/2009 |
STERN'S S250 NORDAM |
CEFLA S.C. |
| K123381 |
11/01/2012 |
HYPERION X9 |
CEFLA S.C. |
| K133412 |
11/07/2013 |
S200, S300 |
CEFLA S.C. |
| K130834 |
03/26/2013 |
R7 |
CEFLA S.C. |
| K190496 |
02/28/2019 |
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS |
CEFLA S.C. |
| K183448 |
12/12/2018 |
NewTom 5G XL |
Cefla S.C. |
| K220664 |
03/07/2022 |
NewTom 7G |
CEFLA S.C. |
| K200688 |
03/16/2020 |
hyperion X5, NewTom GO, X-RADiUS COMPACT |
CEFLA S.C. |
| K213022 |
09/20/2021 |
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. |
| K223794 |
12/19/2022 |
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS |
CEFLA S.C. |
| K214084 |
12/27/2021 |
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS |
CEFLA S.C. |
| K151597 |
06/12/2015 |
Family of Steam Sterilizers B 28 series |
CEFLA S.C. |
| K161848 |
07/05/2016 |
Family of Steam sterilizers B17 B22 Series |
CEFLA S.C. |
| K152162 |
08/03/2015 |
Myray- HYPERION X5 |
CEFLA S.C. |
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