510(k) · Cleared
ClearedSpi Contact 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 Mar 5, 2004 as substantially equivalent to K901927 (Mathys Corp. of North America, 1991) and 6 other predicates after a 72-day review. Its family tree reaches back 3 generations to 1990. 3 later devices descend from it.
- Decided
- Mar 5, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K894595 (1990). 17 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 2 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 1 generation backK030007 Iti Dental Implant SystemStraumann USA · 2003
- This deviceK034014 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −2 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −1 | K030007 | Iti Dental Implant System | Straumann USA | 2003 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K901927 | HA-TI (Hand-Titanium Screw) ImplantSummary page 3…ubstantially equivalent in indications and design principles to the following predicate devices: the HA-Ti Dental Implant System, cleared by FDA on January 4, 1991 under K901927 and July 12, 2001 under K003045; the Thommen SPI® Onetime Dental Implant, cleared on July 15, 2002 under K022038; the Thommen SPI… | 1991 |
| * | K003045 | HA-TI (Hand Titanium Screw) ImplantSummary page 3…ations and design principles to the following predicate devices: the HA-Ti Dental Implant System, cleared by FDA on January 4, 1991 under K901927 and July 12, 2001 under K003045; the Thommen SPI® Onetime Dental Implant, cleared on July 15, 2002 under K022038; the Thommen SPI® Element Dental Implant, cleare… | 2001 |
| * | K022038 | Spi Onetime Dental ImplantSummary page 3…Implant System, cleared by FDA on January 4, 1991 under K901927 and July 12, 2001 under K003045; the Thommen SPI® Onetime Dental Implant, cleared on July 15, 2002 under K022038; the Thommen SPI® Element Dental Implant, cleared on March 4, 2003 under K030689; the Straumann ITI TE Dental Implant, cleared on… | 2002 |
| * | K030689 | Spi Element Dental Implant O 3.5 MMSummary page 3…1 under K003045; the Thommen SPI® Onetime Dental Implant, cleared on July 15, 2002 under K022038; the Thommen SPI® Element Dental Implant, cleared on March 4, 2003 under K030689; the Straumann ITI TE Dental Implant, cleared on March 31, 2003 under K030007; the Steri-Oss Replace Dental Implant cleared on Ma… | 2003 |
| * | K030007 | Iti Dental Implant SystemSummary page 3…2002 under K022038; the Thommen SPI® Element Dental Implant, cleared on March 4, 2003 under K030689; the Straumann ITI TE Dental Implant, cleared on March 31, 2003 under K030007; the Steri-Oss Replace Dental Implant cleared on March 5, 1997 under K964220 and the Branemark Replace Select Dental Implant, cle… | 2003 |
| * | K964220 | Replace Titanium Implant SystemSummary page 3…4, 2003 under K030689; the Straumann ITI TE Dental Implant, cleared on March 31, 2003 under K030007; the Steri-Oss Replace Dental Implant cleared on March 5, 1997 under K964220 and the Branemark Replace Select Dental Implant, cleared on October 11, 2002 under K022562. The SPI® CONTACT Dental Implant has… | 1997 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 3…K030007; the Steri-Oss Replace Dental Implant cleared on March 5, 1997 under K964220 and the Branemark Replace Select Dental Implant, cleared on October 11, 2002 under K022562. The SPI® CONTACT Dental Implant has the following similarities to the predicate devices: *has the same intended use,… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051502 | Spi Dental Implant | 2005 | 2 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K051502 (Thommen Medical AG, 2005) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K901927.
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® CONTACT Dental Implant is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary or mandibular arch to provide support for crowns, bridges or overdentures. SPI® CONTACT 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 implants 0 3.5 mm: These implants are not…
Read the full statement (127 words)
The Thommen SPI® CONTACT Dental Implant is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary or mandibular arch to provide support for crowns, bridges or overdentures. SPI® CONTACT 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 implants 0 3.5 mm:
These implants are not suitable for applications in areas where pronounced rotation moments. translation movements occur, causing the implant to be subjected to large bending moments.
- 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/K034014 · printed Nov 3, 2026
Cite this page
510(k) Report. “K034014: Spi Contact Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K034014
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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