510(k) · Cleared
Recalled · 2007Spi Easy Dental Implant 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 Nov 13, 2002 as substantially equivalent to K901927 (Mathys Corp. of North America, 1991) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1991. 34 later devices descend from it. It has been recalled once.
- Decided
- Nov 13, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K901927 (1991). 2 ancestors in all. 34 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK901927 HA-TI (Hand-Titanium Screw) ImplantMathys Corp. of North America · 1991
- This deviceK023645 Spi Easy Dental Implant AbutmentThommen Medical AG · 2002
- Descendant · cites it directly · 33 of its ownK031747 Spi Dental Implant AbutmentsThommen Medical AG · 2003
- 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 · 4 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
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K031747Spi Dental Implant AbutmentsThommen Medical AG · 2003 · cites it directly33descendants
- K121334VarioecoThommen Medical AG · 2012 · 2 generations on16descendants
- K160244VARIOuniteThommen Medical AG · 2016 · 3 generations on15descendants
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 4 generations on13descendants
- K033346Spi Easy Dental Implant Protective CapThommen Medical AG · 2003 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901927 | HA-TI (Hand-Titanium Screw) Implant | Mathys Corp. of North America | 1991 | — |
| 0 (this device) | K023645 | Spi Easy Dental Implant Abutment | Thommen Medical AG | 2002 | — |
| +1 | K031747 | Spi Dental Implant Abutments | Thommen Medical AG | 2003 | — |
| +2 | K121334 | Varioeco | Thommen Medical AG | 2012 | — |
| +3 | K160244 | VARIOunite | Thommen Medical AG | 2016 | — |
| +4 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| +1 | K033346 | Spi Easy Dental Implant Protective Cap | Thommen Medical AG | 2003 | — |
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 | 2 | 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 30.7 · 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? (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 1…67 and I S 0 5832-2. PREDICATE DEVICE INFORMATION The predicate device for this modification is the HA-Ti Dental Implant System, cleared by FDA on January 4,1991 under K901927 and July 12,2001 under K003045. Thommen Medical AG has acquired the rights to the HA-Ti Dental Implant System from HATI Dental AG… | 1991 |
| * | K003045 | HA-TI (Hand Titanium Screw) ImplantSummary page 1…DEVICE INFORMATION The predicate device for this modification is the HA-Ti Dental Implant System, cleared by FDA on January 4,1991 under K901927 and July 12,2001 under K003045. Thommen Medical AG has acquired the rights to the HA-Ti Dental Implant System from HATI Dental AG and has renamed it the SPP Den… | 2001 |
What descends from it? (34)
See all 344 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 19, 2007 | Not classified | Z-1086-2007 | Other | The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm. |
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.
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@EASY Dental Implant Abutments are intended to be used in conjunction with SPI@System dental implants in the maxillary andor mandibular arch to provide support for crowns, bridges or overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023645: Spi Easy Dental Implant Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023645
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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