510(k) · Cleared
ClearedSpi Dental Implant Abutments
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 Jul 2, 2003 as substantially equivalent to K901927 (Mathys Corp. of North America, 1991) and 1 other predicate after a 27-day review. Its family tree reaches back 2 generations to 1991. 33 later devices descend from it.
- Decided
- Jul 2, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901927 (1991). 3 ancestors in all. 33 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK901927 HA-TI (Hand-Titanium Screw) ImplantMathys Corp. of North America · 1991
- 1 generation backK023645 Spi Easy Dental Implant AbutmentThommen Medical AG · 2002 · Recalled
- This deviceK031747 Spi Dental Implant AbutmentsThommen Medical AG · 2003
- Descendant · cites it directly · 16 of its ownK121334 VarioecoThommen Medical AG · 2012
- Descendant · 2 generations on · 15 of its ownK160244 VARIOuniteThommen Medical AG · 2016
- Descendant · 3 generations on · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- Descendant · cites it directly · 12 of its ownK033346 Spi Easy Dental Implant Protective CapThommen Medical AG · 2003
- Descendant · cites it directly · 11 of its ownK051527 Spi Easy Temporary CapThommen Medical AG · 2005
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K121334VarioecoThommen Medical AG · 2012 · cites it directly16descendants
- K160244VARIOuniteThommen Medical AG · 2016 · 2 generations on15descendants
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 3 generations on13descendants
- K033346Spi Easy Dental Implant Protective CapThommen Medical AG · 2003 · cites it directly12descendants
- K051527Spi Easy Temporary CapThommen Medical AG · 2005 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901927 | HA-TI (Hand-Titanium Screw) Implant | Mathys Corp. of North America | 1991 | — |
| −1 | K023645 | Spi Easy Dental Implant Abutment | Thommen Medical AG | 2002 | 1 |
| 0 (this device) | K031747 | Spi Dental Implant Abutments | Thommen Medical AG | 2003 | — |
| +1 | K121334 | Varioeco | Thommen Medical AG | 2012 | — |
| +2 | K160244 | VARIOunite | Thommen Medical AG | 2016 | — |
| +3 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| +1 | K033346 | Spi Easy Dental Implant Protective Cap | Thommen Medical AG | 2003 | — |
| +1 | K051527 | Spi Easy Temporary Cap | Thommen Medical AG | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 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? (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 |
|---|---|---|---|
| * | K901927 | HA-TI (Hand-Titanium Screw) ImplantSummary page 2…Page 2: of 2 PREDICATE DEVICE INFORMATION The predicate devices for this modification are the HA-Ti Dental Implant System, cleared by FDA on January 4,1991 under K901927 and SPI Easy Dental Implant Abutment (Thommen A.G.), cleared on November 13,2002 under KO23645 Thommen Medical AG has acquired th… | 1991 |
| * | K023645 | Spi Easy Dental Implant Abutment | 2002 |
What descends from it? (33)
See all 337 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121334 | Varioeco | 2012 | 16 |
| K033346 | Spi Easy Dental Implant Protective Cap | 2003 | 12 |
| K051527 | Spi Easy Temporary Cap | 2005 | 11 |
| K092248 | Spi Customizable Gingiva Former | 2009 | 10 |
| K101714 | Nobelprocera TI Abutment Thommen Platforms | 2010 | 1 |
| K111984 | Spi Vario Angled Abutment | 2011 | 0 |
| K110171 | Nobelprocera ZI Abutment Thommen Platforms | 2011 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K121334 (Thommen Medical AG, 2012) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K901927.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Dental Implant 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/K031747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031747: Spi Dental Implant Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031747
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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