FDA 510(k) Applications Submitted by LORENZO BORTOLOTTI

FDA 510(k) Number Submission Date Device Name Applicant
K110260 01/28/2011 NEWTOM 5G / NEWTOM 5G VERSION FP QR S.R.L.
K220664 03/07/2022 NewTom 7G CEFLA S.C.
K200688 03/16/2020 hyperion X5, NewTom GO, X-RADiUS COMPACT CEFLA S.C.
K151612 06/15/2015 NewTom VGi evo QR S.r.l.
K142222 08/13/2014 NewTom 5G QR S.r.l.
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.


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