510(k) · Cleared
ClearedSpi Variomulti Abutment
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 Feb 15, 2008 after a 133-day review. The FDA summary names no predicate by number. 45 later devices descend from it.
- Decided
- Feb 15, 2008
- Review
- 133 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 3 citing it directly.
- This deviceK072856 Spi Variomulti AbutmentThommen Medical AG · 2008
- Descendant · cites it directly · 43 of its ownK101798 Spi Variomulti Angled AbutmentThommen Medical AG · 2010
- Descendant · cites it directly · 32 of its ownK103252 Camlog Vario SR AbutmentsAltatec GmbH · 2011
- Descendant · 2 generations on · 16 of its ownK121334 VarioecoThommen Medical AG · 2012
- Descendant · 3 generations on · 15 of its ownK160244 VARIOuniteThommen Medical AG · 2016
- Descendant · 2 generations on · 14 of its ownK113779 Conelog Implant SystemAltatec GmbH · 2012
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K101798Spi Variomulti Angled AbutmentThommen Medical AG · 2010 · cites it directly43descendants
- K103252Camlog Vario SR AbutmentsAltatec GmbH · 2011 · cites it directly32descendants
- K121334VarioecoThommen Medical AG · 2012 · 2 generations on16descendants
- K160244VARIOuniteThommen Medical AG · 2016 · 3 generations on15descendants
- K113779Conelog Implant SystemAltatec GmbH · 2012 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072856 | Spi Variomulti Abutment | Thommen Medical AG | 2008 | — |
| +1 | K101798 | Spi Variomulti Angled Abutment | Thommen Medical AG | 2010 | — |
| +1 | K103252 | Camlog Vario SR Abutments | Altatec GmbH | 2011 | — |
| +2 | K121334 | Varioeco | Thommen Medical AG | 2012 | — |
| +3 | K160244 | VARIOunite | Thommen Medical AG | 2016 | — |
| +2 | K113779 | Conelog Implant System | Altatec GmbH | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 30.7 · 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?
The FDA summary names no predicate by number.
What descends from it? (45)
See all 453 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?
- Of its descendants, K101798 (Thommen Medical AG, 2010) has gone furthest, with 43 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 SPI® VARIOmulti Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072856 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072856: Spi Variomulti Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072856
Report an extraction error
Are you the manufacturer?
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