FDA.reportPublic FDA data

Straumann Manufacturing, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30241857243024185724Straumann Manufacturing, Inc.1Y2026-01-011961 Heritage Parkway Mansfield TX US 76063
30337811083033781108Straumann Manufacturing, Inc.1N2026-01-0160 Minuteman Road Andover MA US 01810
30051064053005106405Straumann Manufacturing, Inc.1Y2020-04-25916 113th St Ste A ARLINGTON TX US 76011

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2105951021107698K994119SYNOCTA ANGLED ABUTMENTSDZE2000-03-17
2105951120690560K990342SYNOCTA PROSTHETICSDZE1999-07-20
2105951613886780K984104ITI DENTAL IMPLANT SYSTEMDZE1999-05-13
2105951688927994K983742ITI DENTAL IMPLANT SYSTEMDZE1999-03-15
2105951691618498K973353BONDING BASEDZE1997-12-02
2105951083736607K971578ENDOSSEOUS DENTAL IMPLANTDZE1997-06-30
2105951711345608K962647ANGLED ABUTMENTDZE1996-10-07
2105951306758055K960634TITANIUM HEALING CAPSDZE1996-06-18
2105951412349454K894844BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTSDZE1990-02-02
3090851869557706K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueNHA2026-05-07
3090851652750276K250614Neodent Implant System - Custom AbutmentsNHA2025-05-27
3090851851516270K250271Neodent Implant System - Zirconia Implant SystemDZE2025-08-18
3090851131810599K243278Custom AbutmentsNHA2025-02-21
3090851049437895K242686Neodent Implant SystemNHA2024-12-04
2105951643772952K241575Straumann® Anatomic Healing Abutments XC (AHA)NHA2024-11-11
3090851262660737K233857Neodent Implant System – Custom AbutmentsNHA2024-05-02
3090851752576150K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit AbutmentsNHA2024-04-15
3090851400005746K201711CARES Screw - Retained Bars and Bridges (SRBB)NHA2020-12-08
2105951202989738K200586Straumann TLX Implant SystemDZE2020-08-20
3090851202989738K200586Straumann TLX Implant SystemDZE2020-08-20
3090851654936267K193301coDiagnostiXDZJ2021-06-21
2105951655479006K192893Straumann Ceramic Healing AbutmentsNHA2020-01-03
2105951244706699K192742Straumann Variobase CNHA2021-02-12
2105951656945777K191256Straumann BLX Ø3.5 mm ImplantsDZE2019-12-27
2105951117811623K190654Straumann CI RD Ceramic Healing CapsNHA2019-06-28
3090851225234901K190097Straumann CARES Screw-Retained Bridges and BarsNHA2019-06-26
2105951109839403K190040Straumann BLX Line Extension - New AbutmentsNHA2019-04-08
3090851109839403K190040Straumann BLX Line Extension - New AbutmentsNHA2019-04-08
2105951517343645K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsDZE2018-12-28
2105951295506827K180477Straumann PURE Ceramic Implant SystemDZE2019-01-04
809301906829984K173968Straumann Variobase for Bridge/Bar CylindricalNHA2018-07-17
3090851906829984K173968Straumann Variobase for Bridge/Bar CylindricalNHA2018-07-17
809301972094243K173961Straumann BLX Implant SystemDZE2018-06-05
2105951972094243K173961Straumann BLX Implant SystemDZE2018-06-05
3090851972094243K173961Straumann BLX Implant SystemDZE2018-06-05
809301760478684K173379Straumann Variobase for Crown ASNHA2018-03-30
3090851760478684K173379Straumann Variobase for Crown ASNHA2018-03-30
809302034181122K172798Straumann CARES Abutments CoCrNHA2018-01-03
3090852034181122K172798Straumann CARES Abutments CoCrNHA2018-01-03
3090851218418704K170838Medentika CAD/CAM TiBasesNHA2017-09-15
809301549110149K162890BLT 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
2105951549110149K162890BLT 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
809301362813159K162848Straumann CARES Golden Ti/TiN AbutmentsNHA2017-09-22
2105951377363920K161677Straumann Sterile Healing SolutionNHA2016-10-07
809301257495709K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,EIH2016-09-16
809301116051944K153624Neodent Implant SystemNHA2016-04-15
3090851116051944K153624Neodent Implant SystemNHA2016-04-15
2105951762656908K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsDZE2015-07-24
809301738595940K150899Straumann CARES Titanium Alloy (TAN) AbutmentNHA2015-09-16
2105951738595940K150899Straumann CARES Titanium Alloy (TAN) AbutmentNHA2015-09-16
809301144208121K150367Neodent Implant SystemNHA2015-07-13
3090851144208121K150367Neodent Implant SystemNHA2015-07-13
3090851488425823K150203Medentika CAD/CAM AbutmentsNHA2015-10-23
809301050801990K142890Straumann 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
2105951050801990K142890Straumann 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
2105951983708510K140878STRAUMANN BONE LEVEL TAPERED IMPLANTDZE2014-08-20
809301259376659K140737STRAUMANN CARES SCREW RETAINED BARS/BRIDGENHA2014-08-14
3090851259376659K140737STRAUMANN CARES SCREW RETAINED BARS/BRIDGENHA2014-08-14
3090851885741444K133421STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREWNHA2014-04-17
809301555984843K132844STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGESNHA2014-01-15
809301304670265K132219STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,NHA2014-02-21
2105951304670265K132219STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,NHA2014-02-21
2105951895323496K130808STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWSNHA2013-06-28
2105951632477839K122855TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTSDZE2012-12-12
2105951471126797K121131BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MMDZE2012-06-06
809301642419714K120822STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, STNHA2012-12-21
2105951642419714K120822STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, STNHA2012-12-21
809301990327979K112710ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZREIH2011-10-17
809302062135936K112280STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUMNHA2011-11-16
809301582794838K102128VITABLOCSEIH2010-08-11
809301717690789K101465STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BARNHA2010-12-13
809301613370021K093113ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENTNHA2009-12-18
2105951643245245K083550STRAUMANN DENTAL IMPLANT SYSTEMDZE2009-02-26
3090852052154920K082764STRAUMANN WN CARES TITANIUM ABUTMENTNHA2008-10-01
809301272268353K082545STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTSNHA2008-10-17
2105951928145270K081005P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTSNHA2008-05-02
3090851928145270K081005P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTSNHA2008-05-02
2105952022494056K072151P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTSNHA2007-09-11
3090852022494056K072151P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTSNHA2007-09-11
2105951432354592K071585P.004 HEALING ABUTMENTS AND CLOSURE SCREWSNHA2007-07-11
809301360073923K071548WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLOREDEBG2007-08-21
2105951194840622K062129P.0004 IMPLANTSDZE2006-10-20
809301213556070K061804ZERION ALPHA, ; ZERION BETAEIH2006-10-06
809301512790766K061277STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPINGNHA2007-04-12
2105951933039838K061176STRAUMANN DENTAL IMPLANTSDZE2006-08-11
2105951323825535K053088SLACTIVE IMPLANTSDZE2006-02-27
3090851633944714K052272STRAUMANN COMPUTER AIDED RESTORATION SERVICENHA2006-01-03
3090851776618092K041295RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANTNHA2004-05-24
2105951347958208K041070STRAUMANN TEMPORARY COPINGNHA2004-07-23
2105951468652535K033984STRAUMANN DENTAL IMPLANT SYSTEMDZE2004-06-30
2105952004604361K033922MODIFICATION TO ITI DENTAL IMPLANT SYSTEMDZE2004-01-07
2105952002841728K013798PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEMDZE2001-12-19
2105951157281657K012757ITI DENTAL IMPLANT SYSTEMDZE2001-08-22
2105951133954356K010291ITI DENTAL IMPLANT SYSTEMDZE2001-05-10
2105951285143184K003552ITI DENTAL IMPLANT SYSTEMDZE2001-08-17
2105951672188939K003271MODIFICATION TO ITI DENTAL IMPLANT SYSTEMDZE2001-03-20
809301860250044K001799DC-TELLEBF2000-08-10
809301101383980
809301548884971
3090851006078310
3090851050801990
3090851071287626
2105951101383980
3090851101383980
3090851106046386
3090851167324462
3090851213556070
3090851226988819
3090851247916371
3090851257495709
3090851263953618
3090851267890506
3090851272268353
3090851304670265
3090851360073923
3090851362813159
3090851473684958
3090851512790766
3090851528583309
3090851548884971

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA552026-05-07
DZE352025-08-18
EIH42016-09-16
DZJ12021-06-21
EBG12007-08-21
EBF12000-08-10

PMN#