Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011221537

FEI Number

3011221537

Entity Name

etkon GMBH

City/State/Country

Markkleeberg Saxony, DE

Establishment Address

Koburger Strasse 45, Markkleeberg Saxony 04416, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INSTITUT STRAUMANN AG (Owner Number: 9005052)

Owner / Operator Contact Address

PETER MERIAN-WEG 12, BASEL, CH-NOTA CH-4002, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112710

PMA Number

N/A

All Registered Proprietary Names

Straumann CARES Screw-Retained Bridge and Dolder Bar STRAUMANN DENTAL IMPLANT SYSTEM polycon ae restoration Strauamnn CARES Dolder Bar Titanium Straumann CARES Screw-retained Bridge Titanium Porcelain powder Straumann Variobase for Crown AS Straumann CARES CS2 Scanner CARES Abutment SRBB Bone Level n!ce® for Planmill Straumann® CARES® Golden Ti/TiN Abutments Roxolid BLX Implants 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 Abutments, with screw, D 3.9mm, H 3.75mm, TAN RC Variobase®, for crown, with screw, D 4.5mm, H 5.5mm, TAN WN Variobase Abutments, with screw, D 7mm, H 4.5mm, TAN RC Variobase Abutments, with screw, D 4.5mm, 3.5mm, TAN WN Variobase®, for crown, with screw, D 7mm, H 6.5mm, TAN RN Variobase Abutments, with screw, D 55mm, H 4mm, TAN NNC Variobase®, for crown, with screw, D 3.9mm, H 5.75mm, TAN RN Variobase®, for crown, with screw, D 55mm, H 6mm, TAN n!ce Crown n!ce Inlay n!ce Partial Crown n!ce Veneer n!ce Onlay Straumann CARES Abutments Straumann Custom Abutment AS Straumann CARES Abutments STRAUMANN DENTAL IMPLANT SYSTEM Straumann CARES Abutments ticon and coron restorations polyamide restoration Dental Implant Accesories Straumann Variobase Abutments zerion and glass ceramic restorations Straumann CARES Abutments Straumann Dental Implant System zerion HT elements

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-07-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2007-06-29
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2010-01-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-11-18
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2011-07-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-04-12
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2011-01-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-01-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-08-10
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2017-11-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-07-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-07-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-08-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-08-01
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-11-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-03-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2010-01-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-07-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-12-04
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2007-06-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-01-29
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2008-03-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-03-27
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-01-07
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2007-06-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-07-12
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2008-02-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-19
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2013-02-22

Official Correspondent

Andreas Petermann

US Agent Details

Jennifer M Jackson Business: Straumann USA, LLC Email: jennifer.jackson@straumann.com Phone: (978) 7472509

Related Public Records

Same Entity

INSTITUT STRAUMANN AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010377510	DENTAL WINGS GMBH	Chemnitz Saxony, DE
1222315	Straumann USA, LLC	ANDOVER, MA, US
3007130440	ClearCorrect , LLC	Round Rock, TX, US
3026444199	Medentika GmbH	Calw Baden-Wurttemberg, DE
3007218081	Straumann Villeret SA	Corgemont Bern, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011221537. Last updated year: 2026. Please use registration number 3011221537 when referencing this establishment in official correspondence.