510(k) · Cleared
ClearedSpi Onetime Dental Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paxmed International · DZE Implant, Endosseous, Root-Form
Cleared on Jul 15, 2002 as substantially equivalent to K003045 (Hati Dental Ag., 2001) after a 21-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Jul 15, 2002
- Review
- 21 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003045 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003045 HA-TI (Hand Titanium Screw) ImplantHati Dental Ag. · 2001
- This deviceK022038 Spi Onetime Dental ImplantPaxmed International · 2002
- Descendant · cites it directly · 3 of its ownK034014 Spi Contact Dental ImplantThommen Medical AG · 2004
- Descendant · cites it directly · 2 of its ownK051502 Spi Dental ImplantThommen Medical AG · 2005
- Descendant · 2 generations on · 1 of its ownK093615 Spi Dental Implant, ElementThommen Medical AG · 2010
- Descendant · 3 generations on · 0 of its ownK171795 Thommen Implant SystemThommen Medical AG · 2017
Most influential descendants
Showing 4 of 4 · See all- K034014Spi Contact Dental ImplantThommen Medical AG · 2004 · cites it directly3descendants
- K051502Spi Dental ImplantThommen Medical AG · 2005 · cites it directly2descendants
- K093615Spi Dental Implant, ElementThommen Medical AG · 2010 · 2 generations on1descendant
- K171795Thommen Implant SystemThommen Medical AG · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003045 | HA-TI (Hand Titanium Screw) Implant | Hati Dental Ag. | 2001 | — |
| 0 (this device) | K022038 | Spi Onetime Dental Implant | Paxmed International | 2002 | — |
| +1 | K034014 | Spi Contact Dental Implant | Thommen Medical AG | 2004 | — |
| +1 | K051502 | Spi Dental Implant | Thommen Medical AG | 2005 | — |
| +2 | K093615 | Spi Dental Implant, Element | Thommen Medical AG | 2010 | — |
| +3 | K171795 | Thommen Implant System | Thommen Medical AG | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 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 |
|---|---|---|---|
| * | K003045 | HA-TI (Hand Titanium Screw) Implant | 2001 |
What descends from it? (4)
2 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 DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The Thommen SPI@ONETIME Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.
SPI@ONETIME implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022038 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022038: Spi Onetime Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022038
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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