FDA.reportPublic FDA data

Dentsply Sirona Orthodontics Inc.

Matched from indexed company URL: DENTSPLY SIRONA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10362121036212Dentsply Sirona Orthodontics Inc.1Y2026-01-017290 26th Court East Sarasota FL US 34243
16499953001947560Dentsply Sirona Orthodontics Inc.1N2026-01-011125 E Campbell Rd Ste 100 RICHARDSON TX US 75081
30048841503004884150DENTSPLY SIRONA INC1N2026-01-01221 W Philadelphia St Ste 60w York PA US 17401
20862113001586030Dentsply Sirona Orthodontics Inc.1Y2020-04-25280 AVENIDA CAMPILLO STE J CALEXICO CA US 92231

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
D746PUMOG1Posterior Lower Pontic - Posterior Upper Pontic Set - Gray Set of 8+1(800)883-8733sales@essix.com
D746PUMOG1Posterior Lower Pontic - Posterior Upper Pontic Set - Gray Set of 8+1(844)848-0137essix.sales@dentsplysirona.com

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
1412391167972067K922499REFLECTIONS - CERAMIC DENTAL BRACKETEJF1992-07-30
2367331938443510K260722SureSmile Aligner (ASSY500020)NXC2026-04-15
2367331684198045K253565SureSmile SoftwarePNN2026-03-04
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
2367331595159397K171860Sureclear alignersNXC2018-01-05
3457801199318987K171122CEREC Ortho SoftwarePNN2018-01-11
3457801241699270K170500SIROLaser Advance+GEX2017-05-16
3457801689419069K163714OSSIX BONENPM2017-07-18
1412391333934395K163155MTM Clear AlignerNXC2017-02-03
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
1412391153880356K132145MTM(R) CLEAR ALIGNERNXC2013-10-11
3457801015816806K131319T1/T2/T3 TURBINE FAMILYEFB2014-05-30
1412391462096846K123925MTM CLEAR ALIGNER IN-OFFICENXC2013-05-24
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
1412391873968171K092030ELATION MB METAL REINFORCED PLASTIC BRACKETDYW2009-07-24
1412391072067026K090454ALLURE MB CERAMIC BRACKETSNJM2009-03-20
3457801539702504K083344HELIODENT PLUSEHD2008-12-23
1412391657933684K082974MYSTIQUE MB CERAMIC BRACKETSNJM2008-11-07
3457801186984748K080882CEREC OPTI SPRAYELW2008-04-11
1412391676516868K080246COMPOSITE ALIGNER BUTTONNXC2008-04-11
1412391584116870K072522THERMOFORM SHEET MATERIALS AND ACCESSORIESMQC2007-11-16
1412391816627095K062828MOUTHGUARD AND ALIGNER MATERIALSMQC2006-11-27
1412391965015062K060836VISTADENT OC - VERSION 4LLZ2006-10-27
1412391044110349K053368INTERPROXIMAL REDUCTION SYSTEMEFB2006-03-29
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
2367331117724265K002620SURESMILE SYSTEMEIA2000-11-16
1412391038047394
1412391138789642
1412391140794781
1412391147812230
1412391214451657
1412391235463921
1412391259858292
1412391265198837
1412391285172911
1412391340007421
1412391347116199
1412391406337521
1412391438566132
1412391445235455
1412391551896334
1412391624532138
1412391646775811
1412391646795082
1412391652769001
1412391666254191
1412391678722230
1412391691666886
1412391776896318
1412391840003839
1412391936570130
1412391959683304
1412391969505735
1412392008077674
2367332018329748
1412392064426041
1412391035737669
2367331035737669
1412391041372107
1412391075190190
2367331111104015
3457801265198837
1412391324931125
1412391326033461
1412391349050331
3457801380390155
1412391386001033
1412391389362822
1412391413517943
3457801480216004
1412391489927009
3457801523093412
3457801631845077
3457801674573742
2367331678722230
3457801678722230
3457801689620610
1412391731352728
1412391833371632
1412391869599463
2367331936570130
3457802018329748
1412392046677122
3457802046677122

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NXC82026-04-15
NHA52025-04-30
OAS52020-06-22
MQC32023-10-12
NPL32022-07-18
EIH32018-08-01
GEX32018-03-08
EIA32015-07-24
EFB32014-05-30
LLZ32014-02-25
PNN22026-03-04
NJM22009-03-20
EHD22008-12-23
ELC22005-09-02
NTK12025-08-29
EBG12020-10-27
NDP12019-09-27
NPM12017-07-18
EGS12015-07-02
DYW12009-07-24
ELW12008-04-11
EKX12005-09-06
EBZ12004-04-28
EFA11997-03-19
EJF11992-07-30

PMN#

Axeos

2020-06-22

Dentsply Sirona

69 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next