FDA.reportPublic FDA data

INSTITUT STRAUMANN AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96133483004975279INSTITUT STRAUMANN AG1N2026-01-01PETER MERIAN-WEG 12 BASEL Basel-Stadt CH CH-4002

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
07630031770936Straumann Variobase Abutments XC for Bridge/Bar - NT Variobase XC for Bridge/Bar AS, incl. screw, Ø 4.2mm, AH 7mm, TAN+1(800)448-8168info.usa@straumann.com
07630031770943Straumann Variobase Abutments XC for Bridge/Bar - RT Variobase XC for Bridge/Bar AS, incl. screw, Ø 5mm, AH 7mm, TAN+1(800)448-8168info.usa@straumann.com
07630031770950Straumann Variobase Abutments XC for Bridge/Bar - WT Variobase XC for Bridge/Bar AS, incl. screw, Ø 7mm, AH 7mm, TAN+1(800)448-8168info.usa@straumann.com
07630031770967Straumann Variobase Abutments XC for Bridge/Bar - NT Variobase XC for Bridge/Bar, incl. screw, Ø 4mm, AH 7mm, TAN+1(800)448-8168info.usa@straumann.com
07630031770974Straumann Variobase Abutments XC for Bridge/Bar - RT Variobase XC for Bridge/Bar, incl. screw, Ø 5mm, AH 7mm, TAN+1(800)448-8168info.usa@straumann.com
07630031770981Straumann Variobase Abutments XC for Bridge/Bar - WT Variobase XC for Bridge/Bar, incl. screw, Ø 7mm, AH 7mm, TAN+1(800)448-8168info.usa@straumann.com
07630031770998Straumann Variobase Abutments XC for Bridge/Bar - RB/WB Variobase XC for Crown AS, incl. screw, Ø 4.5mm, GH 1.5mm, AH 7mm, TAN+1(800)448-8168info.usa@straumann.com
07630031782298Straumann Modular Cassette - B Module, Tray Scanbodies, PPSU/silicone+1(800)448-8168info.usa@straumann.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
453261813184077P930021BIORA EMDOGAIN(R)NQA1996-09-30
453261021107698K994119SYNOCTA ANGLED ABUTMENTSDZE2000-03-17
453261628832192K990458STRAUMANN EXTRAORAL IMPLANT SYSTEMKCZ1999-04-16
453261120690560K990342SYNOCTA PROSTHETICSDZE1999-07-20
453261613886780K984104ITI DENTAL IMPLANT SYSTEMDZE1999-05-13
453261688927994K983742ITI DENTAL IMPLANT SYSTEMDZE1999-03-15
453261861600078K980986PROCADEIH1998-05-11
453261691618498K973353BONDING BASEDZE1997-12-02
453261083736607K971578ENDOSSEOUS DENTAL IMPLANTDZE1997-06-30
453261711345608K962647ANGLED ABUTMENTDZE1996-10-07
453261081254329K962023PLASTIC PROTECTION HEALING CAPSDZE1996-08-15
453261306758055K960634TITANIUM HEALING CAPSDZE1996-06-18
453261129021023K955369MEMFIXDZL1996-01-23
453261737361031K943720ITI TRANSVERSAL SCREWING SYSTEMDZE1995-03-24
453261984445356K931993ITI DISTANCE SYSTEMDZE1994-04-26
453261412349454K894844BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTSDZE1990-02-02
453261953614341K253315Straumann Variobase Abutments XC for Bridge/BarNHA2026-01-22
453261113085181K252168Straumann® BLC Implants - Indication WideningDZE2026-03-10
453261955101541K250294Straumann® RidgeFit ImplantsDZE2025-08-12
453261877926785K243478Straumann InLab Validated WorkflowNHA2025-02-19
453261131810599K243278Custom AbutmentsNHA2025-02-21
453261643772952K241575Straumann® Anatomic Healing Abutments XC (AHA)NHA2024-11-11
453261493557230K234049Straumann® BLC and TLC Implants - Line extensionDZE2024-03-20
453261083225247K233252Straumann CARES Visual and Nova Dental CADPNP2024-12-26
453261089589736K230108Straumann® BLC and TLC ImplantsDZE2023-09-14
453261048355737K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsNHA2023-05-15
453261412377787K220878Straumann TLX Variobase CNHA2022-06-16
453261894697145K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMANHA2022-06-02
453261948304312K213063TLX SRAs and TLX Gold AbutmentsNHA2022-04-08
453261240547165K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsDZE2022-01-28
453261976478841K211052Straumann RidgeFit ImplantsDZE2021-07-08
453261413206072K210855Straumann BLX Implant SystemDZE2021-06-21
453262031870211K203753Straumann Surgical CassettesKCT2021-07-29
453261696099746K203355Straumann TLX Novaloc and Cementable AbutmentsNHA2021-02-12
453261526680344K202942Straumann 4 mm Short ImplantsDZE2021-02-08
453261675667576K201681Straumann Immediate Temporary AbutmentsNHA2021-03-18
453261855821346K201051Straumann BoneCeramicLYC2020-09-24
453261323515626K200597Straumann BLX Gold AbutmentsNHA2020-08-19
453261202989738K200586Straumann TLX Implant SystemDZE2020-08-20
453261757934540K193046Straumann® Retentive System – Novaloc TiN AbutmentsNHA2020-08-13
453261655479006K192893Straumann Ceramic Healing AbutmentsNHA2020-01-03
453261244706699K192742Straumann Variobase CNHA2021-02-12
453261738154701K192401Straumann Screw-Retained AbutmentsNHA2020-04-06
453261242175777K192029Straumann PUREloc abutmentsNHA2019-10-28
453262064411820K191895Straumann Mini ImplantsDZE2019-12-09
453261705591193K191522Straumann Modular CassetteKCT2019-12-03
453261656945777K191256Straumann BLX Ø3.5 mm ImplantsDZE2019-12-27
453261117811623K190654Straumann CI RD Ceramic Healing CapsNHA2019-06-28
453261225234901K190097Straumann CARES Screw-Retained Bridges and BarsNHA2019-06-26
453261109839403K190040Straumann BLX Line Extension - New AbutmentsNHA2019-04-08
453261517343645K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsDZE2018-12-28
453261886638902K180791Straumann BLX Surgical CassetteKCT2018-06-21
453261295506827K180477Straumann PURE Ceramic Implant SystemDZE2019-01-04
453261906829984K173968Straumann Variobase for Bridge/Bar CylindricalNHA2018-07-17
453261972094243K173961Straumann BLX Implant SystemDZE2018-06-05
453261894730899K173410n!ce for PlanmillEIH2017-11-14
453261760478684K173379Straumann Variobase for Crown ASNHA2018-03-30
453262034181122K172798Straumann CARES Abutments CoCrNHA2018-01-03
453261294565690K171773Straumann n!ce Glass Ceramic A14 BlocksNHA2017-12-01
453261739233282K171757Straumann Screw Retained AbutmentsNHA2017-11-27
453261279490079K171649Straumann CARES M-Series CAD/CAM SystemNHA2018-02-22
453261599714735K170420n!ce Glass Ceramic Blocks for Amann GirrbachEIH2017-03-02
453261549110149K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES AbutmentDZE2017-03-08
453261377363920K161677Straumann Sterile Healing SolutionNHA2016-10-07
453261257495709K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,EIH2016-09-16
453261901378272K153758Straumann Bone Level Tapered ImplantsDZE2016-03-23
453261285006592K151590Straumann RN Gold Abutment for BridgeNHA2016-03-04
453261930171203K151328PURE Ceramic ImplantsDZE2016-01-11
453261568185950K151324Straumann Variobase for CERECNHA2015-09-11
453261994228680K151247NC Straumann Screw Retained AbutmentsNHA2015-08-10
453261885580853K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/BridgesNHA2015-08-05
453261762656908K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsDZE2015-07-24
453261738595940K150899Straumann CARES Titanium Alloy (TAN) AbutmentNHA2015-09-16
453261050801990K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single UnitNHA2015-01-09
453261550259768K141871Straumann Bone Level NC Angled Screw Retained AbutmentsNHA2014-08-07
453261983708510K140878STRAUMANN BONE LEVEL TAPERED IMPLANTDZE2014-08-20
453261259376659K140737STRAUMANN CARES SCREW RETAINED BARS/BRIDGENHA2014-08-14
453261885741444K133421STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREWNHA2014-04-17
453261555984843K132844STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGESNHA2014-01-15
453261304670265K132219STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,NHA2014-02-21
453261895323496K130808STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWSNHA2013-06-28
453261632477839K122855TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTSDZE2012-12-12
453262000873174K122192NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEMNHA2012-11-02
453261471126797K121131BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MMDZE2012-06-06
453261642419714K120822STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, STNHA2012-12-21
453261361900473K113606NNC GOLD ABUTMENT FOR BRIDGESNHA2012-01-27
453261124682696K113410NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENTNHA2012-01-13
453261803701617K113283NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTSNHA2011-12-28
453261683314719K113246OCS-BNPM2013-01-16
453261990327979K112710ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZREIH2011-10-17
453262062135936K112280STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUMNHA2011-11-16
453261624764897K111724STRAUMANN TIBRUSHELB2011-09-12
453261427990275K111357STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEMDZE2011-10-03
453261064703986K110580NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTSNHA2011-08-12
453261644102157K102307GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELSNPL2011-05-04
453261582794838K102128VITABLOCSEIH2010-08-11
453261717690789K101465STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BARNHA2010-12-13
453261613370021K093113ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENTNHA2009-12-18
453261282286228K093027STRAUMANN RC TEMPORARY ABUTMENTSDZE2010-02-12
453261587300469K092814STRAUMANN DENTAL ABUTMENTSNHA2009-12-15
453261179697964K091701STRAUMANN MODIFIED DENTAL ABUTMENTNHA2009-12-22
453261978659478K090260MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTSDZE2009-02-26
453261643245245K083550STRAUMANN DENTAL IMPLANT SYSTEMDZE2009-02-26
453262052154920K082764STRAUMANN WN CARES TITANIUM ABUTMENTNHA2008-10-01
453261272268353K082545STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTSNHA2008-10-17
453261678620643K082532STRAUMANN GUIDED INSTRUMENTSDZI2008-10-21
453261949952025K082111STRAUMANN MEMBRAGELNPK2009-05-22
453261417423547K081419STRAUMANN DENTAL IMPLANT SYSTEMDZE2009-02-20
453261928145270K081005P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTSNHA2008-05-02
453262040807769K080286CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPSNHA2008-03-07
453261891340135K080239P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGSNHA2008-04-30
453261431485995K073628SYNOCTA ABUTMENTSNHA2008-01-22
453261020816793K072679P.004 ABUTMENTSNHA2007-10-12
453261757393352K072497P.004 NC GOLD ABUTMENT FOR CROWNSNHA2007-09-26
453262022494056K072151P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTSNHA2007-09-11
453261504882178K072071STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPSNHA2007-08-15
453261228132680K071919P.004 ABUTMENTSNHA2007-09-26
453261122850449K071888STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGESNHA2007-10-15
453261830520165K071636CODIAGNOSTIX (R) 5.72LLZ2007-08-09
453261432354592K071585P.004 HEALING ABUTMENTS AND CLOSURE SCREWSNHA2007-07-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA752026-01-22
DZE532026-03-10
EIH82017-11-14
KCT32021-07-29
LYC22020-09-24
DZL22005-04-05
PNP12024-12-26
NPM12013-01-16
ELB12011-09-12
NPL12011-05-04
NPK12009-05-22
DZI12008-10-21
EBG12007-08-21
LLZ12007-08-09
KJJ12007-01-12
OAT12006-02-03
EBF12000-08-10
KCZ11999-04-16
NQA11996-09-30

PMN#

85 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next