FDA.reportPublic FDA data

Straumann Villeret SA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96144043002807318Straumann Villeret SA1N2026-01-01LES CHAMPS DU CLOS 2 VILLERET Bern CH CH-2613
30072180813007218081Straumann Villeret SA1N2026-01-01Grand-Rue 53a Corgemont Bern CH CH-2606

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
453271021107698K994119SYNOCTA ANGLED ABUTMENTSDZE2000-03-17
453271628832192K990458STRAUMANN EXTRAORAL IMPLANT SYSTEMKCZ1999-04-16
453271120690560K990342SYNOCTA PROSTHETICSDZE1999-07-20
453271613886780K984104ITI DENTAL IMPLANT SYSTEMDZE1999-05-13
453271688927994K983742ITI DENTAL IMPLANT SYSTEMDZE1999-03-15
453271691618498K973353BONDING BASEDZE1997-12-02
453271083736607K971578ENDOSSEOUS DENTAL IMPLANTDZE1997-06-30
453271711345608K962647ANGLED ABUTMENTDZE1996-10-07
453271081254329K962023PLASTIC PROTECTION HEALING CAPSDZE1996-08-15
453271306758055K960634TITANIUM HEALING CAPSDZE1996-06-18
453271129021023K955369MEMFIXDZL1996-01-23
453271737361031K943720ITI TRANSVERSAL SCREWING SYSTEMDZE1995-03-24
453271984445356K931993ITI DISTANCE SYSTEMDZE1994-04-26
453271412349454K894844BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTSDZE1990-02-02
453271953614341K253315Straumann Variobase Abutments XC for Bridge/BarNHA2026-01-22
453271113085181K252168Straumann® BLC Implants - Indication WideningDZE2026-03-10
453271877926785K243478Straumann InLab Validated WorkflowNHA2025-02-19
453271643772952K241575Straumann® Anatomic Healing Abutments XC (AHA)NHA2024-11-11
453271493557230K234049Straumann® BLC and TLC Implants - Line extensionDZE2024-03-20
453271089589736K230108Straumann® BLC and TLC ImplantsDZE2023-09-14
453271412377787K220878Straumann TLX Variobase CNHA2022-06-16
453271894697145K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMANHA2022-06-02
453271948304312K213063TLX SRAs and TLX Gold AbutmentsNHA2022-04-08
453271240547165K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsDZE2022-01-28
453271413206072K210855Straumann BLX Implant SystemDZE2021-06-21
453272031870211K203753Straumann Surgical CassettesKCT2021-07-29
453271696099746K203355Straumann TLX Novaloc and Cementable AbutmentsNHA2021-02-12
453271526680344K202942Straumann 4 mm Short ImplantsDZE2021-02-08
2106141526680344K202942Straumann 4 mm Short ImplantsDZE2021-02-08
453271675667576K201681Straumann Immediate Temporary AbutmentsNHA2021-03-18
453271323515626K200597Straumann BLX Gold AbutmentsNHA2020-08-19
453271202989738K200586Straumann TLX Implant SystemDZE2020-08-20
453271757934540K193046Straumann® Retentive System – Novaloc TiN AbutmentsNHA2020-08-13
2106141757934540K193046Straumann® Retentive System – Novaloc TiN AbutmentsNHA2020-08-13
453271244706699K192742Straumann Variobase CNHA2021-02-12
453271738154701K192401Straumann Screw-Retained AbutmentsNHA2020-04-06
453271242175777K192029Straumann PUREloc abutmentsNHA2019-10-28
2106141242175777K192029Straumann PUREloc abutmentsNHA2019-10-28
453271705591193K191522Straumann Modular CassetteKCT2019-12-03
453271656945777K191256Straumann BLX Ø3.5 mm ImplantsDZE2019-12-27
453271117811623K190654Straumann CI RD Ceramic Healing CapsNHA2019-06-28
2106141117811623K190654Straumann CI RD Ceramic Healing CapsNHA2019-06-28
453271225234901K190097Straumann CARES Screw-Retained Bridges and BarsNHA2019-06-26
453271109839403K190040Straumann BLX Line Extension - New AbutmentsNHA2019-04-08
2106141109839403K190040Straumann BLX Line Extension - New AbutmentsNHA2019-04-08
453271517343645K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsDZE2018-12-28
453271295506827K180477Straumann PURE Ceramic Implant SystemDZE2019-01-04
453271906829984K173968Straumann Variobase for Bridge/Bar CylindricalNHA2018-07-17
453271972094243K173961Straumann BLX Implant SystemDZE2018-06-05
453271760478684K173379Straumann Variobase for Crown ASNHA2018-03-30
453271739233282K171757Straumann Screw Retained AbutmentsNHA2017-11-27
453271279490079K171649Straumann CARES M-Series CAD/CAM SystemNHA2018-02-22
453271549110149K162890BLT 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
453271901378272K153758Straumann Bone Level Tapered ImplantsDZE2016-03-23
453271285006592K151590Straumann RN Gold Abutment for BridgeNHA2016-03-04
453271930171203K151328PURE Ceramic ImplantsDZE2016-01-11
453271568185950K151324Straumann Variobase for CERECNHA2015-09-11
453271994228680K151247NC Straumann Screw Retained AbutmentsNHA2015-08-10
453271885580853K151157NC 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
453271762656908K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsDZE2015-07-24
453271050801990K142890Straumann 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
453271550259768K141871Straumann Bone Level NC Angled Screw Retained AbutmentsNHA2014-08-07
453271983708510K140878STRAUMANN BONE LEVEL TAPERED IMPLANTDZE2014-08-20
453271885741444K133421STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREWNHA2014-04-17
453271555984843K132844STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGESNHA2014-01-15
453271304670265K132219STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,NHA2014-02-21
453271895323496K130808STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWSNHA2013-06-28
453271632477839K122855TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTSDZE2012-12-12
453272000873174K122192NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEMNHA2012-11-02
453271471126797K121131BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MMDZE2012-06-06
453271642419714K120822STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, STNHA2012-12-21
453271361900473K113606NNC GOLD ABUTMENT FOR BRIDGESNHA2012-01-27
453271124682696K113410NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENTNHA2012-01-13
453271803701617K113283NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTSNHA2011-12-28
453272062135936K112280STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUMNHA2011-11-16
453271427990275K111357STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEMDZE2011-10-03
453271064703986K110580NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTSNHA2011-08-12
453271282286228K093027STRAUMANN RC TEMPORARY ABUTMENTSDZE2010-02-12
453271587300469K092814STRAUMANN DENTAL ABUTMENTSNHA2009-12-15
453271179697964K091701STRAUMANN MODIFIED DENTAL ABUTMENTNHA2009-12-22
453271978659478K090260MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTSDZE2009-02-26
453271643245245K083550STRAUMANN DENTAL IMPLANT SYSTEMDZE2009-02-26
453272052154920K082764STRAUMANN WN CARES TITANIUM ABUTMENTNHA2008-10-01
453271272268353K082545STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTSNHA2008-10-17
453271678620643K082532STRAUMANN GUIDED INSTRUMENTSDZI2008-10-21
453271417423547K081419STRAUMANN DENTAL IMPLANT SYSTEMDZE2009-02-20
453271928145270K081005P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTSNHA2008-05-02
453272040807769K080286CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPSNHA2008-03-07
453271891340135K080239P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGSNHA2008-04-30
453271431485995K073628SYNOCTA ABUTMENTSNHA2008-01-22
453271020816793K072679P.004 ABUTMENTSNHA2007-10-12
453271757393352K072497P.004 NC GOLD ABUTMENT FOR CROWNSNHA2007-09-26
453272022494056K072151P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTSNHA2007-09-11
453271504882178K072071STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPSNHA2007-08-15
453271228132680K071919P.004 ABUTMENTSNHA2007-09-26
453271122850449K071888STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGESNHA2007-10-15
453271432354592K071585P.004 HEALING ABUTMENTS AND CLOSURE SCREWSNHA2007-07-11
453271675467100K071357P.004 NC ANATOMIC ABUTMENTSNHA2007-09-26
453271515699957K070744NARROW NECK TEMPORARY COPINGNHA2007-06-29
453271753179578K070549STRAUMANN P.004 RC GOLD ABUTMENTNHA2007-08-31
453271901102365K070478P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)NHA2007-09-20
453271549092167K063789WN SYNOCTA GOLD ABUTMENTNHA2007-05-10
453271194840622K062129P.0004 IMPLANTSDZE2006-10-20
453271512790766K061277STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPINGNHA2007-04-12
453271933039838K061176STRAUMANN DENTAL IMPLANTSDZE2006-08-11
453272026433929K060958STRAUMANN NARROW NECK IMPLANTSDZE2006-08-24
453271341670584K060062STRAUMANN ORTHOSYSTEMOAT2006-02-03
453271323825535K053088SLACTIVE IMPLANTSDZE2006-02-27
453271633944714K052272STRAUMANN COMPUTER AIDED RESTORATION SERVICENHA2006-01-03
453271482132258K051717RN SYNOCTA TEMPORARY MESO ABUTMENTNHA2005-07-07
453271688599549K050515BONE BLOCK FIXATION SETDZL2005-04-05
453271776618092K041295RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANTNHA2004-05-24
453271347958208K041070STRAUMANN TEMPORARY COPINGNHA2004-07-23
453271985617547K040539ELLIPTIC MATRIXNHA2004-03-18
453271468652535K033984STRAUMANN DENTAL IMPLANT SYSTEMDZE2004-06-30
453272004604361K033922MODIFICATION TO ITI DENTAL IMPLANT SYSTEMDZE2004-01-07
453271375024096K033243ITI SYNOCTA MESO ABUTMENTSNHA2003-10-20
453271011738586K032498DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)NHA2003-08-27
453271663415313K022859ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEMDZE2002-09-19
453271578502976K020096ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEMDZE2002-02-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA692026-01-22
DZE512026-03-10
KCT22021-07-29
DZL22005-04-05
DZI12008-10-21
OAT12006-02-03
KCZ11999-04-16