FDA.reportPublic FDA data

CEFLA S.C.

Matched from indexed company URL: Cefla S.C.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066108453006610845CEFLA S.C.1N2026-01-01VIA BICOCCA 14/C IMOLA Bologna IT 40026
30114802043011480204CEFLA S.C.1N2020-04-25Via Fermi, 40 VERONA Verona IT 37136

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
218801721961949K260716NeowiseLLZ2026-05-04
218801500126362K252353myray ProXIma X6OAS2026-03-10
218801264774607K231990Apex LocatorLQY2024-02-13
218801018816483K230895CEFLA 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,EBW2024-04-01
218801572171560K223794hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS2023-01-17
218801099156897K220664NewTom 7GJAK2022-05-06
218801195633318K211688DC-Air and Athlos-1 and Athlos-AirMUH2021-07-22
218801751940370K210312PlutoX Digital Intraoral X-Ray Imaging SystemMUH2021-04-23
218801162789389K200688hyperion X5, NewTom GO, X-RADiUS COMPACTOAS2020-04-09
218801933665732K190496hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS2019-04-24
2020291891686571K183448NewTom 5G XLJAK2019-03-08
218801891686571K183448NewTom 5G XLJAK2019-03-08
218801020153817K163519RX DCEHD2017-01-13
218801456446797K161900HYPERION X5OAS2016-12-09
218802052193277K161848Family of Steam sterilizers B17 B22 SeriesFLE2017-02-23
218801642636956K152162Myray- HYPERION X5MUH2015-12-24
2020291488688738K151612NewTom VGi evoOAS2016-03-31
218801488688738K151612NewTom VGi evoOAS2016-03-31
218801803199847K151597Family of Steam Sterilizers B 28 seriesFLE2016-03-04
2020291044595147K142222NewTom 5GJAK2015-01-26
218801718856312K133412S200, S300EIA2015-01-08
218801622091085K130834R7ELC2013-10-08
2020291559364443K130442NEWTOM VGI AND NEWTOM 5GOAS2013-07-03
218801556883882K123381HYPERION X9OAS2013-05-10
218801829484921K100960WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORSMUH2010-10-21
218801416812117K092917STERN'S S250 NORDAMEIA2010-06-24
218801830841659K080076RX DC X-RAY UNITEHD2008-03-14
218801611420673K062897C-U2EIA2006-12-14
218801795221984K050263MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BUFLE2006-11-21
218801376324963
218801559879972
218801695689482
218801721300610
218801886920475
218801928164394

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OAS92026-03-10
JAK42022-05-06
MUH42021-07-22
FLE32017-02-23
EIA32015-01-08
EHD22017-01-13
LLZ12026-05-04
EBW12024-04-01
LQY12024-02-13
ELC12013-10-08

PMN#

R7

2013-10-08

CEFLA S.C.

HYPERION

2012-01-17

CEFLA S.C. CEFLA DENTAL GROUP

C-U2

2006-12-14

CEFLA S.C.R.L.