510(k) · Cleared
ClearedSpi Element Dental Implant O 3.5 MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thommen Medical AG · DZE Implant, Endosseous, Root-Form
Cleared on Mar 26, 2003 as substantially equivalent to K003045 (Hati Dental Ag., 2001) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- Mar 26, 2003
- Review
- 21 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K901927 (1991). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK901927 HA-TI (Hand-Titanium Screw) ImplantMathys Corp. of North America · 1991
- This deviceK030689 Spi Element Dental Implant O 3.5 MMThommen Medical AG · 2003
- 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 | K901927 | HA-TI (Hand-Titanium Screw) Implant | Mathys Corp. of North America | 1991 | — |
| 0 (this device) | K030689 | Spi Element Dental Implant O 3.5 MM | Thommen Medical AG | 2003 | — |
| +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 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K003045 | HA-TI (Hand Titanium Screw) Implant | 2001 |
| * | K901927 | HA-TI (Hand-Titanium Screw) ImplantSummary page 1…E INFORMATION The principal predicate devices for this modification are the HA-Ti Dental Implants, cleared by FDA on July 12,2001 under KO03045 and on Jan 04,1991 under K901927. Thommen Medical AG has acquired the rights to the HA-Ti Dental Implant System from HATI Dental AG and has renamed it the SP$ Den… | 1991 |
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 ELEMENT 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. SPl@ELEMENT implant 0 3.5 mm should be employed only at locations where the available bone structure (minimum width of alveolar ridge: 5-6 mm) precludes the use of a larger diameter. Blocking of multiple SPJ? ELEMENT implants 0 3.5 mm is recommended whenever possible. These…
Read the full statement (225 words)
The Thommen SPI ELEMENT 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.
SPl@ELEMENT implant 0 3.5 mm should be employed only at locations where the available bone structure (minimum width of alveolar ridge: 5-6 mm) precludes the use of a larger diameter. Blocking of multiple SPJ? ELEMENT implants 0 3.5 mm is recommended whenever possible. These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements (e.g. use of single implants for the restoration of canines).
Partially edentulous lower and upper jaw:
$PI@ELEMENT implants 0 3.5 mm are suitable for alloplastic replacement of the lateral incisors (12,22 = FDI System) in the upper jaw and the central and lateral incisors (41,31,42 and 32 = FDI System) in the lower jaw.
Edentulous lower jaw:
4 SPP ELEMENT implant 0 3.5 mm connected with a bar
Edentulous lower and upper jaw:
Complete bridges in combination with 0 4.2 mm, 5.0 mm or 6.0 mm SPI@implants
Contraindications for the use of SPI$ ELEMEm implant 0 3.5 mm:
- Restoration of posterior teeth in the upper or lower jaw
- Single-tooth restoration of canines and central incisors in the upper jaw
- Any application involving retentive anchors
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030689: Spi Element Dental Implant O 3.5 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030689
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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