510(k) · Cleared
ClearedSpi Variomulti Angled 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 Aug 19, 2010 as substantially equivalent to K090153 (Thommen Medical AG, 2009) and 1 other predicate after a 52-day review. Its family tree reaches back 1 generation to 2008. 43 later devices descend from it.
- Decided
- Aug 19, 2010
- Review
- 52 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K072856 (2008). 2 ancestors in all. 43 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK072856 Spi Variomulti AbutmentThommen Medical AG · 2008
- This deviceK101798 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
- Descendant · 4 generations on · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- 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
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072856 | Spi Variomulti Abutment | Thommen Medical AG | 2008 | — |
| 0 (this device) | 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 | — |
| +4 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 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 30.6 · 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? (2)
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 |
|---|---|---|---|
| * | K090153 | Spi Variomulti Angled AbutmentSummary page 2…ical devices, SPI® VARlOrnulti Angled Abutment is substantially equivalent in indications and design principles to the predicate devices, SPI® VARI0multi Angled Abutment K0901 53 and SPI® VARl0multi Abutment K072856. The subject device has the same intended use as the predicate devices and has the same Ind… | 2009 |
| * | K072856 | Spi Variomulti AbutmentSummary page 2…Abutment is substantially equivalent in indications and design principles to the predicate devices, SPI® VARI0multi Angled Abutment K0901 53 and SPI® VARl0multi Abutment K072856. The subject device has the same intended use as the predicate devices and has the same Indications for Use Statement as the pre… | 2008 |
What descends from it? (43)
See all 432 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?
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101798: Spi Variomulti Angled Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101798
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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