Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005106408

FEI Number

3005106408

Entity Name

etkon GMBH

City/State/Country

GRAEFELFING, BAVARIA, DE

Establishment Address

LOCHHAMER SCHLAG 6, GRAEFELFING, BAVARIA 82166, 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

K093113

PMA Number

N/A

All Registered Proprietary Names

Straumann CARES CS2 Scanner CARES Abutment

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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

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

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005106408. Last updated year: 2026. Please use registration number 3005106408 when referencing this establishment in official correspondence.