510(k) · Cleared
ClearedEtkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 18, 2009 as substantially equivalent to K061277 (Straumann USA, 2007) and 6 other predicates after a 78-day review. Its family tree reaches back 10 generations to 1990. 169 later devices descend from it.
- Decided
- Dec 18, 2009
- Review
- 78 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K894844 (1990). 22 ancestors in all. 169 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 6 generations between
- 3 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 2 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 1 generation backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- This deviceK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- Descendant · cites it directly · 167 of its ownK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- Descendant · cites it directly · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 2 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · 2 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Show all 10 generations
- Root · 10 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 9 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 8 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 7 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 6 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 5 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 4 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 3 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 2 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 1 generation backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- This deviceK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
Showing 5 of 169 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 169 · See all- K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010 · cites it directly167descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · cites it directly165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 2 generations on129descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 2 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −9 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −8 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −7 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −6 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −5 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −4 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −3 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −2 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −1 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| 0 (this device) | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| +1 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| +1 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +2 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +2 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 10 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 0 |
| 2021 | 17 | 0 |
| 2022 | 14 | 0 |
| 2023 | 24 | 0 |
| 2024 | 24 | 0 |
| 2025 | 25 | 0 |
| 2026 | 11 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic CopingSummary page 1….....ccccveereenrrenrerersnneonees 3D Dental Lab Scanner Predicate Devices Dental Restoration Design Software Dental Abutment Straumann Computer-aided Restoration.... K061277 (C.A.R.E.S.) Ceramic Coping Straumann NN CARES...........cvorveeeeeenneens K082545 Titanium and Ceramic Abutments Straumann WN… | 2007 |
| * | K082545 | Straumann NN Cares Titanium and Ceramic AbutmentsSummary page 1…Restoration Design Software Dental Abutment Straumann Computer-aided Restoration.... K061277 (C.A.R.E.S.) Ceramic Coping Straumann NN CARES...........cvorveeeeeenneens K082545 Titanium and Ceramic Abutments Straumann WN CARES.........cuevevvevevivennnns K082764 Titanium Abutment P.004 NC CARES.....cocc… | 2008 |
| * | K082764 | Straumann WN Cares Titanium AbutmentSummary page 1…061277 (C.A.R.E.S.) Ceramic Coping Straumann NN CARES...........cvorveeeeeenneens K082545 Titanium and Ceramic Abutments Straumann WN CARES.........cuevevvevevivennnns K082764 Titanium Abutment P.004 NC CARES.....cocccoeerrireerieieeeere e K081005 Titanium and Ceramic Abutments £ straumann Institet S… | 2008 |
| * | K081005 | P.004 NC Cares Titanium and Ceramic AbutmentsSummary page 1…eeenneens K082545 Titanium and Ceramic Abutments Straumann WN CARES.........cuevevvevevivennnns K082764 Titanium Abutment P.004 NC CARES.....cocccoeerrireerieieeeere e K081005 Titanium and Ceramic Abutments £ straumann Institet Straumann AG P.004 RC CARES..........ccvveverrerreeenenens… | 2008 |
| * | K072151 | P.004 RC Cares Titanium and Ceramic AbutmentsSummary page 2….....cocccoeerrireerieieeeere e K081005 Titanium and Ceramic Abutments £ straumann Institet Straumann AG P.004 RC CARES..........ccvveverrerreeenenens K072151 Titanium and Ceramic Abutments Straumann Computer aided....................... K052272 Restoration Service ' Procera® Software .… | 2007 |
| * | K052272 | Straumann Computer Aided Restoration ServiceSummary page 2…stitet Straumann AG P.004 RC CARES..........ccvveverrerreeenenens K072151 Titanium and Ceramic Abutments Straumann Computer aided....................... K052272 Restoration Service ' Procera® Software .........cccceveevevvvirevceerionnen K053602 Nobel Biocare AB Description for the'Premar… | 2006 |
| * | K053602 | Procera Software, Model 33145Summary page 2…2151 Titanium and Ceramic Abutments Straumann Computer aided....................... K052272 Restoration Service ' Procera® Software .........cccceveevevvvirevceerionnen K053602 Nobel Biocare AB Description for the'Premarket Notification etkon™ _visual is a software package by Institut Straumann AG which… | 2006 |
What descends from it? (169)
See all 1693 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K101465 (Institut Straumann AG, 2010) has gone furthest, with 167 descendants of its own.
- 3 other devices also cite its predicate K061277.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093113: Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093113
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026