FDA.reportPublic FDA data

DENTSPLY SIRONA INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30048841503004884150DENTSPLY SIRONA INC1N2026-01-01221 W Philadelphia St Ste 60w York PA US 17401

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3457801624662197K972436T1 LINE DENTAL HANDPIECESEFB1997-09-22
3457801564124832K965238T1 CONTROL HIGH SPEED DENTAL HANDPIECEEFA1997-03-19
3457801808190059K250771Primescan 2NTK2025-08-29
3457801966779089K250295Dentsply Sirona Titanium Bases systemNHA2025-04-30
3457801844752359K232448FREEPRINT® splintmasterMQC2023-10-12
3457801686237264K230199Byte Aligner SystemNXC2023-10-18
3457801272055341K212509OSSIX BreezeNPL2022-07-18
3457801395026813K201140AxeosOAS2020-06-22
3457801745065257K200273FREEPRINT tempEBG2020-10-27
3457801686110104K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareNHA2020-08-16
3457801577584439K191616Orthophos SOAS2019-07-16
3457801337136580K190059CEREC GuidesNDP2019-09-27
3457801354963608K181520Sirona Dental CAD/CAM SystemNHA2018-10-11
3457801975915482K180703VITA YZ ST and VITA YZ XTEIH2018-08-01
3457801978898604K180346Byte Aligner SystemNXC2019-02-19
3457802039428220K180044SIROLaser BlueGEX2018-03-08
3457801199318987K171122CEREC Ortho SoftwarePNN2018-01-11
3457801241699270K170500SIROLaser Advance+GEX2017-05-16
3457801689419069K163714OSSIX BONENPM2017-07-18
3457801788049727K160281OSSIX PLUSNPL2016-08-04
3457802065453630K153549OSSIX VOLUMAXNPL2016-08-04
3457801857364421K151045TENEO Dental Treatment Unit and AccessoriesEIA2015-07-24
3457801395514157K150909INTEGO Family and AccesoriesEIA2015-07-17
3457801054402346K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SprayEGS2015-07-02
3457801598748403K150217ORTHOPHOS SLOAS2015-05-08
3457801576007661K133320SICAT FUNCTIONLLZ2014-02-25
3457801018135329K132773SIDEXIS 4LLZ2013-12-11
3457801015816806K131319T1/T2/T3 TURBINE FAMILYEFB2014-05-30
3457801557622179K123545INCORIS TZIEIH2013-02-01
3457801783731927K123070GALILEOS FAMILYOAS2013-03-15
3457801871286082K111421SIRONA DENTAL CAD/CAM SYSTEMNHA2012-02-17
3457801581097316K103753SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASERGEX2011-02-15
3457801936375740K103711ORTHOPHOS XG 3D / CEPHOAS2011-03-22
3457802064337434K102128VITABLOCSEIH2010-08-11
3457801386076597K100152SIRONA CAD/CAM SYSTEMNHA2010-10-22
3457801539702504K083344HELIODENT PLUSEHD2008-12-23
3457801186984748K080882CEREC OPTI SPRAYELW2008-04-11
3457801603841375K052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131ELC2005-09-02
3457802043690897K051661IMPLANT HANDPIECESEKX2005-09-06
3457801935509269K040808MINI L.E.D. OEM MODULEEBZ2004-04-28
3457801584473099K033640SIROSON L AND SIROSONIC L ULTRASONIC SCALERSELC2003-12-12
3457801560494733K033073ORTHOPHOS XG DS/CEPHEHD2003-10-10
3457801265198837
3457801380390155
3457801480216004
3457801523093412
3457801631845077
3457801674573742
3457801678722230
3457801689620610
3457802018329748
3457802046677122

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA52025-04-30
OAS52020-06-22
NPL32022-07-18
EIH32018-08-01
GEX32018-03-08
NXC22023-10-18
EIA22015-07-24
EFB22014-05-30
LLZ22014-02-25
EHD22008-12-23
ELC22005-09-02
NTK12025-08-29
MQC12023-10-12
EBG12020-10-27
NDP12019-09-27
PNN12018-01-11
NPM12017-07-18
EGS12015-07-02
ELW12008-04-11
EKX12005-09-06
EBZ12004-04-28
EFA11997-03-19