510(k) · Cleared
ClearedSpi Dental Implant
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 Jun 21, 2005 as substantially equivalent to K003034 (Coltene/Whaledent, Inc., 2000) and 3 other predicates after a 14-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Jun 21, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K894595 (1990). 19 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 3 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 2 generations backK030007 Iti Dental Implant SystemStraumann USA · 2003
- 1 generation backK034014 Spi Contact Dental ImplantThommen Medical AG · 2004
- This deviceK051502 Spi Dental ImplantThommen Medical AG · 2005
- Descendant · cites it directly · 1 of its ownK093615 Spi Dental Implant, ElementThommen Medical AG · 2010
- Descendant · 2 generations on · 0 of its ownK171795 Thommen Implant SystemThommen Medical AG · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −3 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −2 | K030007 | Iti Dental Implant System | Straumann USA | 2003 | — |
| −1 | K034014 | Spi Contact Dental Implant | Thommen Medical AG | 2004 | — |
| 0 (this device) | K051502 | Spi Dental Implant | Thommen Medical AG | 2005 | — |
| +1 | K093615 | Spi Dental Implant, Element | Thommen Medical AG | 2010 | — |
| +2 | K171795 | Thommen Implant System | Thommen Medical AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K003034 | Coltene Aura Compomer Restorative SystemSummary page 1…832-2. PREDICATE DEVICE INFORMATION The principal predicate device for this modification is the Thommen Medical AG, SPI® Dental Implant System, cleared by FDA under K0030345, K022038, K030689, K034014. PACKAGING/LABELING/PRODUCT INFORMATION Thommen SPI® Dental Implants will be packaged in a radia… | 2000 |
| * | K022038 | Spi Onetime Dental ImplantSummary page 1…REDICATE DEVICE INFORMATION The principal predicate device for this modification is the Thommen Medical AG, SPI® Dental Implant System, cleared by FDA under K0030345, K022038, K030689, K034014. PACKAGING/LABELING/PRODUCT INFORMATION Thommen SPI® Dental Implants will be packaged in a radiation steri… | 2002 |
| * | K030689 | Spi Element Dental Implant O 3.5 MMSummary page 1…DEVICE INFORMATION The principal predicate device for this modification is the Thommen Medical AG, SPI® Dental Implant System, cleared by FDA under K0030345, K022038, K030689, K034014. PACKAGING/LABELING/PRODUCT INFORMATION Thommen SPI® Dental Implants will be packaged in a radiation sterilizable p… | 2003 |
| * | K034014 | Spi Contact Dental ImplantSummary page 1…FORMATION The principal predicate device for this modification is the Thommen Medical AG, SPI® Dental Implant System, cleared by FDA under K0030345, K022038, K030689, K034014. PACKAGING/LABELING/PRODUCT INFORMATION Thommen SPI® Dental Implants will be packaged in a radiation sterilizable package co… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093615 | Spi Dental Implant, Element | 2010 | 1 |
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 15 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K093615 (Thommen Medical AG, 2010) has gone furthest, with 1 descendant of its own.
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® Dental Implant System, TST Surface, is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental 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. Contraindications for the use of SPI® CONTACT implant 0 3.5 mm and SPI®…
Read the full statement (136 words)
The Thommen SPI® Dental Implant System, TST Surface, is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental 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.
Contraindications for the use of SPI® CONTACT implant 0 3.5 mm and SPI® ELEMENT implant o 3.5 mm:
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.
- 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/K051502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051502: Spi Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051502
Report an extraction error
Are you the manufacturer?
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