510(k) · Cleared
ClearedSpi Dental Implant, Element
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 4, 2010 as substantially equivalent to K090154 (Thommen Medical AG, 2009) and 6 other predicates after a 101-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it.
- Decided
- Mar 4, 2010
- Review
- 101 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K894595 (1990). 56 ancestors in all, the oldest K894844 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 4 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 2 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 1 generation backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- This deviceK093615 Spi Dental Implant, ElementThommen Medical AG · 2010
- Descendant · cites it directly · 0 of its ownK171795 Thommen Implant SystemThommen Medical AG · 2017
Most influential descendants
Showing 1 of 1 · See all- K171795Thommen Implant SystemThommen Medical AG · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −4 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −2 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −1 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| 0 (this device) | K093615 | Spi Dental Implant, Element | Thommen Medical AG | 2010 | — |
| +1 | K171795 | Thommen Implant System | Thommen Medical AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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 |
|---|---|---|---|
| * | K090154 | Spi Dental Implant Inicell | 2009 |
| * | K051502 | Spi Dental ImplantSummary page 2…f FDA's regulation of medical devices, the SPI Dental Implant, ELEMENT is substantially equivalent in indications and design principles to predicate devices (KO901 54, KO051502, K050712, K050258, K033984, KOI010185, K926501), each of which has been determined by FDA to be substantially equivalent to pream… | 2005 |
| * | K050712 | 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental ImplantSummary page 2…regulation of medical devices, the SPI Dental Implant, ELEMENT is substantially equivalent in indications and design principles to predicate devices (KO901 54, KO051502, K050712, K050258, K033984, KOI010185, K926501), each of which has been determined by FDA to be substantially equivalent to preamendment d… | 2005 |
| * | K050258 | Groovy ImplantsSummary page 2…n of medical devices, the SPI Dental Implant, ELEMENT is substantially equivalent in indications and design principles to predicate devices (KO901 54, KO051502, K050712, K050258, K033984, KOI010185, K926501), each of which has been determined by FDA to be substantially equivalent to preamendment devices. A… | 2005 |
| * | K033984 | Straumann Dental Implant SystemSummary page 2…cal devices, the SPI Dental Implant, ELEMENT is substantially equivalent in indications and design principles to predicate devices (KO901 54, KO051502, K050712, K050258, K033984, KOI010185, K926501), each of which has been determined by FDA to be substantially equivalent to preamendment devices. A comparis… | 2004 |
| * | K010185 | 6.0 X 5.7MM Dental ImplantSummary page 2…the SPI Dental Implant, ELEMENT is substantially equivalent in indications and design principles to predicate devices (KO901 54, KO051502, K050712, K050258, K033984, KOI010185, K926501), each of which has been determined by FDA to be substantially equivalent to preamendment devices. A comparison of the s… | 2002 |
| * | K926501 | Branemark System (R) - 5.5MM FixtureSummary page 2…Dental Implant, ELEMENT is substantially equivalent in indications and design principles to predicate devices (KO901 54, KO051502, K050712, K050258, K033984, KOI010185, K926501), each of which has been determined by FDA to be substantially equivalent to preamendment devices. A comparison of the surface ar… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171795 | Thommen Implant System | 2017 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 56 ancestors have a recall of any class.
- Of its descendants, K171795 (Thommen Medical AG, 2017) has gone furthest, with 0 descendants 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. 2010, this device’s year, is highlighted.
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?
SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately…
Read the full statement (133 words)
SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.
Contraindications for the use of SPI ELEMENT implant 0 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 and 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/K093615 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093615: Spi Dental Implant, Element.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093615
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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