510(k) · Cleared
ClearedVarioeco
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thommen Medical AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Aug 14, 2012 as substantially equivalent to K071453 (Thommen Medical AG, 2007) and 2 other predicates after a 103-day review. Its family tree reaches back 9 generations to 1990. 16 later devices descend from it.
- Decided
- Aug 14, 2012
- Review
- 103 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K894595 (1990). 84 ancestors in all, the oldest K871863 (1987). 16 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 2 generations backK061477 Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsNobel Biocare AB · 2006
- 1 generation backK103252 Camlog Vario SR AbutmentsAltatec GmbH · 2011
- This deviceK121334 VarioecoThommen Medical AG · 2012
- Descendant · cites it directly · 15 of its ownK160244 VARIOuniteThommen Medical AG · 2016
- Descendant · 2 generations on · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- Descendant · 3 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · 3 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 3 generations on · 2 of its ownK180465 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 6 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 3 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 2 generations backK061477 Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsNobel Biocare AB · 2006
- 1 generation backK103252 Camlog Vario SR AbutmentsAltatec GmbH · 2011
- This deviceK121334 VarioecoThommen Medical AG · 2012
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K160244VARIOuniteThommen Medical AG · 2016 · cites it directly15descendants
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 2 generations on13descendants
- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 3 generations on3descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 3 generations on2descendants
- K180465Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −6 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −3 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| −2 | K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems | Nobel Biocare AB | 2006 | — |
| −1 | K103252 | Camlog Vario SR Abutments | Altatec GmbH | 2011 | — |
| 0 (this device) | K121334 | Varioeco | Thommen Medical AG | 2012 | — |
| +1 | K160244 | VARIOunite | Thommen Medical AG | 2016 | — |
| +2 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| +3 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +3 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +3 | K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 10 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K071453 | Spi Easy 4.0 AbutmentSummary page 2…lOeco is substantially equivalent in indications and design principles to the following legally marketed predicate devices: Thommen Medical AG, SPI® EASY 4.0 Abutment - K071453, Thomamen Medical AG, SPI® Dental Implant Abutments - K03 1747, Altatec GmbH, CAMLOG® Vario SR Abutments - K103252, The subject… | 2007 |
| * | K031747 | Spi Dental Implant AbutmentsSummary page 2…inciples to the following legally marketed predicate devices: Thommen Medical AG, SPI® EASY 4.0 Abutment - K071453, Thomamen Medical AG, SPI® Dental Implant Abutments - K03 1747, Altatec GmbH, CAMLOG® Vario SR Abutments - K103252, The subject VARLOeco abutment and predicates straight SPI EASY Abutment and… | 2003 |
| * | K103252 | Camlog Vario SR AbutmentsSummary page 2…devices: Thommen Medical AG, SPI® EASY 4.0 Abutment - K071453, Thomamen Medical AG, SPI® Dental Implant Abutments - K03 1747, Altatec GmbH, CAMLOG® Vario SR Abutments - K103252, The subject VARLOeco abutment and predicates straight SPI EASY Abutment and straight VarioSR Abutment are all titanium abutment… | 2011 |
What descends from it? (16)
See all 162 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 22 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 84 ancestors have a recall of any class.
- Of its descendants, K160244 (Thommen Medical AG, 2016) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K071453.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Thommen VARIOeco dental implant abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular. arch to provide support for crowns, bridges and overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121334: Varioeco.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121334
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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