DENT4YOU AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30225169283022516928DENT4YOU AG1N2026-01-01Bahnhofstrasse 2 Heerbrugg Sankt Gallen CH 9435

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3051441610330258K983679STATIM 5000 CASSETTE AUTOCLAVEFLE1999-01-04
3051441243474941K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTELW2025-06-27
3051441467164634K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal ActivatorELW2024-11-15
3051442036779973K240801BioSonic US200 Ultrasonic Scaler (60034537)ELC2024-07-01
3051441511707326K223142Coltolux Comfort LED Curing LightEBZ2022-12-22
3051441591916236K220097PRESIDENT The OriginalELW2022-01-13
3051441082628986K210326Bravo G4 Chamber AutoclaveFLE2021-07-01
3051441935710192K192910STATClave G4 Chamber AutoclaveFLE2020-06-19
3051441575991386K190597BRILLIANT EverGlow FlowEBF2019-06-21
3051441483648505K190062STATCLAVE G4 Chamber AutoclaveFLE2019-07-26
3051441034031841K181500BRILLIANT CriosEBF2018-08-15
3051441962434982K152927BRILLIANT EVERGLOWEBF2016-04-28
3051441558860760K112872STATIM 2000 G4 CASSETTEFLE2012-07-10
3051441612371286K062418K-SPRAY, MODEL 085-2715EFB2006-10-19
3051441026019488
3051441319315477
3051441327178488
3051441357911168
3051441390925043
3051441481052443
3051441497977620
3051441620338811
3051441663467730
3051441668966708
3051441699710271
3051441936368698
3051442038753276
3051442066625881

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FLE52021-07-01
ELW32025-06-27
EBF32019-06-21
ELC12024-07-01
EBZ12022-12-22
EFB12006-10-19

PMN#

GUDID#

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