510(k) · Cleared
ClearedSpi Easy Dental Implant Protective Cap
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 3, 2003 as substantially equivalent to K031747 (Thommen Medical AG, 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1991. 12 later devices descend from it.
- Decided
- Nov 3, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K901927 (1991). 4 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK901927 HA-TI (Hand-Titanium Screw) ImplantMathys Corp. of North America · 1991
- 2 generations backK023645 Spi Easy Dental Implant AbutmentThommen Medical AG · 2002 · Recalled
- 1 generation backK031747 Spi Dental Implant AbutmentsThommen Medical AG · 2003
- This deviceK033346 Spi Easy Dental Implant Protective CapThommen Medical AG · 2003
- Descendant · cites it directly · 11 of its ownK051527 Spi Easy Temporary CapThommen Medical AG · 2005
- Descendant · cites it directly · 10 of its ownK092248 Spi Customizable Gingiva FormerThommen Medical AG · 2009
- Descendant · 2 generations on · 9 of its ownK122988 Klockner Dental Implant AbutmentsSoadco, S.L. · 2013
- Descendant · 3 generations on · 4 of its ownK151194 Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016
- Descendant · 3 generations on · 3 of its ownK160221 Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K051527Spi Easy Temporary CapThommen Medical AG · 2005 · cites it directly11descendants
- K092248Spi Customizable Gingiva FormerThommen Medical AG · 2009 · cites it directly10descendants
- K122988Klockner Dental Implant AbutmentsSoadco, S.L. · 2013 · 2 generations on9descendants
- K151194Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016 · 3 generations on4descendants
- K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901927 | HA-TI (Hand-Titanium Screw) Implant | Mathys Corp. of North America | 1991 | — |
| −2 | K023645 | Spi Easy Dental Implant Abutment | Thommen Medical AG | 2002 | 1 |
| −1 | K031747 | Spi Dental Implant Abutments | Thommen Medical AG | 2003 | — |
| 0 (this device) | K033346 | Spi Easy Dental Implant Protective Cap | Thommen Medical AG | 2003 | — |
| +1 | K051527 | Spi Easy Temporary Cap | Thommen Medical AG | 2005 | — |
| +1 | K092248 | Spi Customizable Gingiva Former | Thommen Medical AG | 2009 | — |
| +2 | K122988 | Klockner Dental Implant Abutments | Soadco, S.L. | 2013 | — |
| +3 | K151194 | Klockner Dental Implant Abutments (II) | Soadco, S.L. | 2016 | — |
| +3 | K160221 | Implance Dental Implant System, Implance Dental Abutment System | Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. | 2016 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K031747 | Spi Dental Implant Abutments | 2003 |
| * | K023645 | Spi Easy Dental Implant AbutmentSummary page 2…N The predicate device for this modification is the SPI@Dental Implant System Gingiva Former, cleared by FDA on July 2,2003 under KO31747 and on November 13, 2002 under K023645. PACKAGINGILABELINGIPRODUCT INFORMATION Thommen SPl@EASY Dental Implant Protective Cap will be packaged and sold non- sterile.… | 2002 |
What descends from it? (12)
See all 122 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 12 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K051527 (Thommen Medical AG, 2005) has gone furthest, with 11 descendants of its own.
- 6 other devices also cite its predicate K031747.
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?
The Thommen SPI@EASY Dental Implant Protective Cap is intended to be used in conjunction with SPI@System dental implants, which provide support for crowns, bridges or overdentures in the maxillary and/or mandibular arch.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033346 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033346: Spi Easy Dental Implant Protective Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033346
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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