FDA.reportPublic FDA data

etkon GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30051064083005106408etkon GMBH1N2026-01-01LOCHHAMER SCHLAG 6 GRAEFELFING, BAVARIA DE 82166
30112215373011221537etkon GMBH1N2026-01-01Koburger Strasse 45 Markkleeberg Saxony DE 04416

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1744651131810599K243278Custom AbutmentsNHA2025-02-21
1744651557857507K210320ClearCorrect SystemNXC2021-08-06
1744651906829984K173968Straumann Variobase for Bridge/Bar CylindricalNHA2018-07-17
1744651972094243K173961Straumann BLX Implant SystemDZE2018-06-05
1744651894730899K173410n!ce for PlanmillEIH2017-11-14
1744651760478684K173379Straumann Variobase for Crown ASNHA2018-03-30
1744652034181122K172798Straumann CARES Abutments CoCrNHA2018-01-03
1744651294565690K171773Straumann n!ce Glass Ceramic A14 BlocksNHA2017-12-01
1744651599714735K170420n!ce Glass Ceramic Blocks for Amann GirrbachEIH2017-03-02
1744651549110149K162890BLT 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
1744651362813159K162848Straumann CARES Golden Ti/TiN AbutmentsNHA2017-09-22
1744651257495709K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,EIH2016-09-16
1744651116051944K153624Neodent Implant SystemNHA2016-04-15
1744651738595940K150899Straumann CARES Titanium Alloy (TAN) AbutmentNHA2015-09-16
1744651144208121K150367Neodent Implant SystemNHA2015-07-13
1744651050801990K142890Straumann 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
1744651259376659K140737STRAUMANN CARES SCREW RETAINED BARS/BRIDGENHA2014-08-14
1744651555984843K132844STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGESNHA2014-01-15
1744651304670265K132219STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,NHA2014-02-21
1744651642419714K120822STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, STNHA2012-12-21
1744651990327979K112710ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZREIH2011-10-17
1744652062135936K112280STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUMNHA2011-11-16
1744651582794838K102128VITABLOCSEIH2010-08-11
1744651717690789K101465STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BARNHA2010-12-13
828631613370021K093113ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENTNHA2009-12-18
1744651613370021K093113ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENTNHA2009-12-18
1744652052154920K082764STRAUMANN WN CARES TITANIUM ABUTMENTNHA2008-10-01
1744651272268353K082545STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTSNHA2008-10-17
1744651928145270K081005P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTSNHA2008-05-02
1744652022494056K072151P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTSNHA2007-09-11
1744651360073923K071548WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLOREDEBG2007-08-21
1744651213556070K061804ZERION ALPHA, ; ZERION BETAEIH2006-10-06
1744651512790766K061277STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPINGNHA2007-04-12
1744651633944714K052272STRAUMANN COMPUTER AIDED RESTORATION SERVICENHA2006-01-03
1744651860250044K001799DC-TELLEBF2000-08-10
1744651101383980
1744651413477030
1744651548884971
828631621658149
1744651826226795
1744652068898593

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA242025-02-21
EIH62017-11-14
DZE22018-06-05
NXC12021-08-06
EBG12007-08-21
EBF12000-08-10