Data / Medical devices / Germany / etkon GMBH
etkon GMBH: FDA-registered device maker in GRAEFELFING Bavaria, Germany, 1 510(k) clearance
etkon GMBH is registered with the FDA (registration 3005106408) in GRAEFELFING Bavaria, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 18, 2009. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005106408
- Address
- Lochhamer Schlag 6, GRAEFELFING Bavaria, Germany, 82166
- Owner or operator
- INSTITUT STRAUMANN AG (9005052)
- Roles
- Manufacturer
- First device listed
- January 24, 2008
- Registered through
- 2027
- Brand names listed
- AS200E, AS260, CARES Abutment, DI-1, DWOS, S300W, SIRIOS, ST 300E and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 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 |
|---|---|---|---|---|---|---|
| December 18, 2009 | K093113 | ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
Compare with other makers
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of Abutment, Implant, Dental, Endosseous
Updated December 18, 2009. 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.