Cefla S.C.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252353myray ProXIma X6March 10, 2026
K230895CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FApril 1, 2024
K231990Apex LocatorFebruary 13, 2024
K223794hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSJanuary 17, 2023
K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LEDMay 9, 2022
K220664NewTom 7GMay 6, 2022
K214084hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSJanuary 20, 2022
K200688hyperion X5, NewTom GO, X-RADiUS COMPACTApril 9, 2020
K190496hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSApril 24, 2019
K183448NewTom 5G XLMarch 8, 2019
K161848Family of Steam sterilizers B17 B22 SeriesFebruary 23, 2017
K163519RX DCJanuary 13, 2017
K161900HYPERION X5December 9, 2016
K151597Family of Steam Sterilizers B 28 seriesMarch 4, 2016
K152162Myray- HYPERION X5December 24, 2015
K133412S200, S300January 8, 2015
K130834R7October 8, 2013
K123381HYPERION X9May 10, 2013
K092917STERN'S S250 NORDAMJune 24, 2010
K081088MYRAY SKYVIEWNovember 6, 2008