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etkon GMBH: FDA-registered device maker in Markkleeberg Saxony, Germany, 32 510(k) clearances

Name: etkon GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

etkon GMBH is registered with the FDA (registration 3011221537) in Markkleeberg Saxony, Germany. It lists 7 device types. The FDA files 32 510(k) clearances under its listings, the newest dated February 21, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3011221537
Address: Koburger Strasse 45, Markkleeberg Saxony, Germany, 04416
Owner or operator: INSTITUT STRAUMANN AG (9005052)
Roles: Manufacturer
First device listed: June 29, 2007
Registered through: 2027
Brand names listed: CARES Abutment, CARES TAN Abutment, Dental Implant Accesories, NC Variobase Abutment with screw, D 3.8mm, H 3.5mm, TAN, NC Variobase Abutments, with screw, D 3.8mm, H 3.5mm, TAN, NC Variobase®, for crown, with screw, D 3.8mm, H 5.5mm, TAN, NNC Variobase Abutment, with screw, D 55mm, H 4mm, TAN, NNC Variobase Abutments, with screw, D 3.9mm, H 3.75mm, TAN and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Powder, Porcelain	EIH	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 21, 2025	K243278	Custom Abutments	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
July 17, 2018	K173968	Straumann Variobase for Bridge/Bar Cylindrical	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
June 5, 2018	K173961	Straumann BLX Implant System	DZE	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
March 30, 2018	K173379	Straumann Variobase for Crown AS	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
January 3, 2018	K172798	Straumann CARES Abutments CoCr	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
December 1, 2017	K171773	Straumann n!ce Glass Ceramic A14 Blocks	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
November 14, 2017	K173410	n!ce for Planmill	EIH	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
September 22, 2017	K162848	Straumann CARES Golden Ti/TiN Abutments	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
March 8, 2017	K162890	BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment	DZE	Substantially Equivalent	Straumann USA, LLC	accessdata.fda.gov
March 2, 2017	K170420	n!ce Glass Ceramic Blocks for Amann Girrbach	EIH	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
September 16, 2016	K160262	n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,	EIH	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
April 15, 2016	K153624	Neodent Implant System	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
September 16, 2015	K150899	Straumann CARES Titanium Alloy (TAN) Abutment	NHA	Substantially Equivalent	Straumann USA, LLC	accessdata.fda.gov
July 13, 2015	K150367	Neodent Implant System	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
January 9, 2015	K142890	Straumann 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 Unit	NHA	Substantially Equivalent	Straumann USA, LLC	accessdata.fda.gov
August 14, 2014	K140737	STRAUMANN CARES SCREW RETAINED BARS/BRIDGE	NHA	Substantially Equivalent	Straumann USA, LLC	accessdata.fda.gov
February 21, 2014	K132219	STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,	NHA	Substantially Equivalent	Straumann USA, LLC	accessdata.fda.gov
January 15, 2014	K132844	STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES	NHA	Substantially Equivalent	Straumann USA, LLC	accessdata.fda.gov
December 21, 2012	K120822	STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
November 16, 2011	K112280	STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM	NHA	Substantially Equivalent	Straumann USA	accessdata.fda.gov
October 17, 2011	K112710	ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR	EIH	Substantially Equivalent	Wieland Dental + Technik GmbH & Co. KG	accessdata.fda.gov
December 13, 2010	K101465	STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
August 11, 2010	K102128	VITABLOCS	EIH	Substantially Equivalent	Vita Zahnfabrik H.Rauter GmbH & Co.	accessdata.fda.gov
December 18, 2009	K093113	ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
October 17, 2008	K082545	STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
October 1, 2008	K082764	STRAUMANN WN CARES TITANIUM ABUTMENT	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
May 2, 2008	K081005	P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
September 11, 2007	K072151	P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS	NHA	Substantially Equivalent	Straumann USA	accessdata.fda.gov
August 21, 2007	K071548	WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED	EBG	Substantially Equivalent	Merz Dental GmbH	accessdata.fda.gov
April 12, 2007	K061277	STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING	NHA	Substantially Equivalent	Straumann USA	accessdata.fda.gov
October 6, 2006	K061804	ZERION ALPHA, ; ZERION BETA	EIH	Substantially Equivalent	Etkon International GmbH	accessdata.fda.gov
January 3, 2006	K052272	STRAUMANN COMPUTER AIDED RESTORATION SERVICE	NHA	Substantially Equivalent	Straumann USA	accessdata.fda.gov

Compare with other makers

Updated February 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.