510(k) · Cleared
ClearedIti Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · DZE Implant, Endosseous, Root-Form
Cleared on Jul 7, 2003 as substantially equivalent to K013570 (Implant Innovations, Inc., 2001) after a 95-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Jul 7, 2003
- Review
- 95 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935544 (1995). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK935544 3I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
- 1 generation backK013570 Osseotite Dental ImplantsImplant Innovations, Inc. · 2001
- This deviceK031055 Iti Dental Implant SystemStraumann USA · 2003
- Descendant · cites it directly · 2 of its ownK050586 Leone Implant SystemLeone S.P.A. · 2006
- Descendant · 2 generations on · 0 of its ownK092674 Simpler Toadstool Mini ImplantPan Global Implant · 2009
- Descendant · cites it directly · 0 of its ownK073622 Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008
- Descendant · 2 generations on · 0 of its ownK070483 Leone Monoimplant for O-Ring OverdentureLeone S.P.A. · 2007
Most influential descendants
Showing 4 of 4 · See all- K050586Leone Implant SystemLeone S.P.A. · 2006 · cites it directly2descendants
- K092674Simpler Toadstool Mini ImplantPan Global Implant · 2009 · 2 generations on0descendants
- K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008 · cites it directly0descendants
- K070483Leone Monoimplant for O-Ring OverdentureLeone S.P.A. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants Modification | Implant Innovations International, Inc. | 1995 | — |
| −1 | K013570 | Osseotite Dental Implants | Implant Innovations, Inc. | 2001 | — |
| 0 (this device) | K031055 | Iti Dental Implant System | Straumann USA | 2003 | — |
| +1 | K050586 | Leone Implant System | Leone S.P.A. | 2006 | — |
| +2 | K092674 | Simpler Toadstool Mini Implant | Pan Global Implant | 2009 | — |
| +1 | K073622 | Easy Grip Dental Implant System | T.F.I. System S.R.L | 2008 | — |
| +2 | K070483 | Leone Monoimplant for O-Ring Overdenture | Leone S.P.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K013570 | Osseotite Dental ImplantsSummary page 1…keted Devices to which Equivalence is Claimed (Predicate Devices) IT1 Dental Implant System implant Innovations Inc. Osseotite Dental Implants(K013570) 4. Description of the Device IT1 implants have an anchorage surface that is grit blasted then acid etched (SLA… | 2001 |
| * | — | ITI Dental Implant System Named without a submission number |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K050586 (Leone S.P.A., 2006) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K013570.
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?
ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031055: Iti Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031055
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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