FDA.reportPublic FDA data

DENTSPLY IH BV

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30118244423011824442DENTSPLY IH BV1N2027-01-01Piri Reisweg 23 Sevenum Limburg NL 5975 RZ

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1854192006712508K994376FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HADZE2000-03-24
1854191395599458K994298FRIOS MICROSAWKMW2000-02-18
1854191674250081K994257LOCATOR IMPLANT ANCHORDZE2000-03-17
1854191083156725K994174FRIALIT-2 MH-2 ABUTMENTDZE2000-04-20
1854191747826263K990304MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEMDZE1999-07-15
1854191526475436K982576FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476DZE1998-10-22
1854192046139102K980698ASTRA TECH IMPLANTS - DENTAL SYSTEMDZE1998-03-19
1854191022477992K980630FRIALIT-2 CORABASEDZE1998-09-04
1854191974968254K974738ASTRA TECH IMPLANT DENTAL SYSTEMDZE1998-11-19
1854191768754849K974737ASTRA TECH IMPLANT DENTAL SYSTEMDZE1998-03-24
1854192036169383K973924FRIOS BONESHIELDJEY1998-05-07
1854191425719079K972278CYTOPLAST REGENTEX TITANIUM 250LYC1997-08-06
1854192042002049K964342CYTOPLAST GBRLYC1997-03-11
1854191513539030K960548AH PLUS ROOT CANAL SEALERKIF1996-04-26
1854191293524721K945847FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACEDZE1996-03-15
1854191090435444K931767ASTRA TECH IMPLANTS-DENTAL SYSTEMDZE1994-02-08
1854191763622498K921479DUCERATIN/DUCERAM LFC DENTAL PORCELAINEIH1992-06-22
1854191273485749K792558CONTAINER SYSTEMFLE1979-12-27
1854191433626538K780301CAULK TYLOKEMA1978-02-28
1854191930568256K261935Surgical and Prosthetic TraysKCT2026-09-04
1854191572531196K243546AH Plus Endodontic SealerKIF2025-02-13
1854191803849301K242462CEREC Cercon 4D CAD/CAM BlocksEIH2024-10-24
1854191689931278K242025Elos Accurate® Hybrid Base™NHA2024-12-10
1854191915661999K241557Cercon® yo MLEIH2024-08-28
1854191180078378K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemNHA2024-05-07
1854191616511900K233865X-Smart Pro; X-Smart Pro+EKX2024-07-24
1854191780632264K231144WashtraysKCT2024-01-16
1854192039859172K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemNHA2023-03-22
1854191733281484K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDZE2022-11-16
1854191498293458K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)DZE2022-11-16
1854191346530418K220791Surgical and Prosthetic TraysKCT2022-05-03
1854191107855146K213449DS Implants abutments provided with the EV connectionNHA2021-11-15
1854191915125503K212281Surgical TraysKCT2022-03-04
1854191511591906K210610PrimeTaper EV Dental ImplantDZE2021-08-27
1854192057488220K202629Dentsply Sirona Universal Spray GlazesEIH2021-01-20
1854191872101207K201703PROXEO Twist Cordless Polishing System PL-40 HEKX2021-02-24
1854191835467215K193064Atlantis suprastructuresNHA2020-03-03
1854191104972075K183079Conometric AbutmentsNHA2019-07-10
1854191241188604K182422Lucitone Denture Base MaterialsEBI2018-12-18
1854191329701157K182288TPH Spectra ST Flowable Composite RestorativeEBF2018-11-20
1854191681928319K181476Prime&Bond active Universal AdhesiveKLE2018-09-28
1854191961915609K172239SIMPLANT 18LLZ2018-04-04
1854191150324452K163350Multibase Abutments EV and ATLANTIS SuprastructuresNHA2017-03-31
1854191298852835K162888CerconEIH2017-02-24
1854191951298708K162158Porcine Anorganic Bone Mineral in Delivery ApplicatorNPM2017-02-09
1854191427916466K162107TPH Spectra+ Universal Composite RestorativeEBF2016-09-27
1854191908966216K161957W&H Implantmed SI-1015 incl. AccessoriesEBW2016-11-23
1854191343158698K161269CELTRA PressEIH2016-08-12
1854191007492723K161118SIMPLANT Online Case Review and SIMPLANT EditorLLZ2016-07-28
1854191224505457K160232Disposable Barrier Sleeves and CoversPEM2016-06-07
1854191140721458K142496Collagen Dental Membrane - Conformable IIBPNPL2014-11-24
1854191899298726K140714PORCINE ANORGANIC BONE MINERALNPM2014-07-16
1854191208710928K140347ANKYLOS C/X IMPLANT SYSTEMDZE2014-08-20
1854191005170314K131644ANKYLOS SYNCONE ABUTMENT 5(DEGREE)NHA2014-01-22
1854191149542215K130999OSSEOSPEED PROFILE EVDZE2013-10-25
1854192053711181K123615IRIS - HIGH STRENGTH GLASS CERAMICEIH2013-02-22
1854191557622179K123545INCORIS TZIEIH2013-02-01
1854191125008656K122268ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOSNHA2012-12-11
1854191654775071K121810OSSEOSPEED ANGLED ABUTMENT EVNHA2013-01-23
1854191986173087K120414OSSEOSPEED PLUSDZE2012-07-31
1854192027015851K112671STERILCONTAINER SYSTEMKCT2012-05-04
1854191872173554K112152CERCON HTEIH2011-11-09
1854191707954997K102341VIPI BLOCKEBG2010-12-16
1854191571154078K101732ASTRA TECH IMPLANT SYSTEMDZE2011-02-23
1854191949865245K101005ASTRA TECH IMPLANT SYSTEM, NEW COMPONENTNHA2011-06-21
1854191044837115K083841ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIALEBF2009-04-14
1854191262914760K083805ANKYLOS C/X DENTAL IMPLANT SYSTEMDZE2009-05-22
1854191298976797K080939SURGICAL HANDPIECES, MIKRO SAW HANDPIECESKMW2008-07-29
1854191379750310K080396OSSEOSPEED NARROWDZE2008-04-30
1854191296317169K080156OSSEOSPEED TM PROFILE SYSTEMDZE2008-09-17
1854191644641810K073075FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMSDZE2008-03-31
1854191606745115K073073ANKYLOS TEMPORARY ABUTMENT BALANCENHA2008-02-12
1854191757017383K073067ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMSDZE2008-02-15
1854192071179310K072878MODIFICATION TO: LOCATOR IMPLANT ANCHORNHA2007-12-03
1854191518363568K072730FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTSNHA2008-03-27
1854191568755029K072624ASTRA TECH IMPLANT SYSTEM, NEW COMPONENTNHA2007-10-01
1854191599459560K070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVEKLE2007-03-14
1854191084932040K063779OSSEOSPEED 4.0S-6MM, MODEL 24619DZE2007-04-27
1854191970698285K060287DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEMEBW2006-05-03
1854191172763712K053384FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEMDZE2006-03-24
1854191168669153K051462MODIFICATION TO: CERCON BASEEIH2005-06-24
1854191958564735K050880DYRACT EXTRA RESTORATIVEEBF2005-04-22
1854191829858498K050208FRIADENT ESTHETICAPNHA2005-06-14
1854191167161798K041509ANKYLOS DENTAL IMPLANT SYSTEMDZE2004-08-26
1854191124019371K041372SMARTLITE PS PEN-STYLE LED CURING LIGHTEBZ2004-06-24
1854191558434467K040421DUCERAGOLD PORCELAINSEIH2004-03-18
1854191179182444K040420DUCERAM PLUS CERAMIC SYSTEMEIH2004-03-18
1854191822023247K040170FRIADENT PLUS DENTAL IMPLANT SYSTEMSDZE2004-10-27
1854191037061205K040144QUIXX POSTERIOR RESTORATIVEEBF2004-04-01
1854191698328171K032750MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLEDZE2003-10-02
1854191705921443K032302XIVE TG ABUTMENTSDZE2003-10-02
1854191519948562K030639XIVE 3.0 DENTAL IMPLANT SYSTEMDZE2003-08-12
1854191980480145K024004XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEMDZE2003-03-03
1854191478748060K023631ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTSNHA2002-11-07
1854191379260477K022796CERCON CERAM S PORCELAINEIH2002-09-06
1854191848869413K021318XIVE DENTAL IMPLANT SYSTEMDZE2002-07-02
1854191199875872K013867XIVE DENTAL IMPLANT SYSTEMDZE2002-03-15
1854191896209542K013438FRIALIT-2 ESTHETICBASE ABUTMENTDZE2001-12-20
1854191895339116K013067FRIALOC DENTAL IMPLANT SYSTEMDZE2002-04-09
1854191621870955K011061SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11EGS2001-06-28
1854191146068456K002469IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)EBW2001-02-07
1854191147812230
1854191672986973
1854191008799621
1854191021711059
1854191028423531
1854191193864441
1854191244884295
1854191278217299
1854191310472630
1854191380390155
1854191389921053
1854191421704517
1854191499232820
1854191527529069
1854191536901643
1854191605838732
1854191631845077

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE362022-11-16
NHA172024-12-10
EIH132024-10-24
KCT52026-09-04
EBF52018-11-20
NPM32017-02-09
EBW32016-11-23
KIF22025-02-13
EKX22024-07-24
KLE22018-09-28
LLZ22018-04-04
KMW22008-07-29
LYC21997-08-06
EBI12018-12-18
PEM12016-06-07
NPL12014-11-24
EBG12010-12-16
EBZ12004-06-24
EGS12001-06-28
JEY11998-05-07
FLE11979-12-27
EMA11978-02-28