510(k) · Cleared
ClearedSpi Art 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 Dec 5, 2007 after a 28-day review. The FDA summary names its predicate without a number. 182 later devices descend from it.
- Decided
- Dec 5, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 0
182 later devices descend from it, 1 citing it directly.
- This deviceK073141 Spi Art AbutmentThommen Medical AG · 2007
- Descendant · cites it directly · 181 of its ownK101207 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2010
- Descendant · 2 generations on · 180 of its ownK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- Descendant · 3 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- Descendant · 2 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- Descendant · 3 generations on · 115 of its ownK133421 Straumann Magellan (TM) Abutment,Protective Cap,Titanium…Straumann USA, LLC · 2014
Showing 5 of 182 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 182 · See all- K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2010 · cites it directly181descendants
- K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · 2 generations on180descendants
- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 3 generations on127descendants
- K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 2 generations on123descendants
- K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC · 2014 · 3 generations on115descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073141 | Spi Art Abutment | Thommen Medical AG | 2007 | — |
| +1 | K101207 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2010 | — |
| +2 | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| +3 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| +2 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| +3 | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold… | Straumann USA, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 17 | 0 |
| 2021 | 19 | 0 |
| 2022 | 18 | 0 |
| 2023 | 24 | 0 |
| 2024 | 19 | 0 |
| 2025 | 27 | 0 |
| 2026 | 17 | 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? (1)
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 |
|---|---|---|---|
| * | — | SPI ART Abutment Named without a submission number |
What descends from it? (182)
See all 1821 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101207 | Neodent Implant System | 2010 | 181 |
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, K101207 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2010) has gone furthest, with 181 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. 2007, 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?
SPI® ART Abutment is 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.
SPI ART Abutment is contraindicated for free-end bridges or bridges with more than one intermediate pontic element.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073141: Spi Art Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073141
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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