# K093113: Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Dec 18, 2009 after 78 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894844 (1990). 22 ancestors in all.
169 later devices descend from it; 3 cite it directly.
0 of 192 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061277: Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping, Straumann USA (2007) Summary page 1.
- K082545: Straumann NN Cares Titanium and Ceramic Abutments, Institut Straumann AG (2008) Summary page 1.
- K082764: Straumann WN Cares Titanium Abutment, Institut Straumann AG (2008) Summary page 1.
- K081005: P.004 NC Cares Titanium and Ceramic Abutments, Institut Straumann AG (2008) Summary page 1.
- K072151: P.004 RC Cares Titanium and Ceramic Abutments, Straumann USA (2007) Summary page 2.
- K052272: Straumann Computer Aided Restoration Service, Straumann USA (2006) Summary page 2.
- K053602: Procera Software, Model 33145, Nobel Biocare AB (2006) Summary page 2.

## Most influential descendants
- K101465: Straumann Cares Bridge; Straumann Cares Dolder Bar (2010), 167 descendants of its own
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own
- K150203: Medentika CAD/CAM Abutments (2015), 129 descendants of its own
- K150367: Neodent Implant System (2015), 89 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own

## Indications for use
etkon_visual is a software device intended to import patient-specific data from a scanner for CAD (computer aided design) design of individual dental restorations like crowns, bridges, inlays, onlays, veneers and abutments. etkon_visual also facilitates the transfer of 3D data from a dental lab to a remote milling center by internet connection and serves as an order management tool.

Source page: https://510kreport.com/device/K093113
Methodology: https://510kreport.com/methodology