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 Aug 22, 2001 as substantially equivalent to K003271 (Institut Straumann AG, 2001) and 1 other predicate after a 5-day review. Its family tree reaches back 2 generations to 1990. 535 later devices descend from it.
- Decided
- Aug 22, 2001
- Review
- 5 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894844 (1990). 4 ancestors in all. 535 later devices descend from it, 11 citing it directly.
- Root · 2 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 1 generation backK990342 Synocta ProstheticsStraumann USA · 1999
- This deviceK012757 Iti Dental Implant SystemStraumann USA · 2001
- Descendant · cites it directly · 434 of its ownK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- Descendant · cites it directly · 376 of its ownK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- Descendant · 2 generations on · 295 of its ownK053088 Slactive ImplantsInstitut Straumann AG · 2006
- Descendant · 2 generations on · 283 of its ownK070478 P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007
- Descendant · 2 generations on · 279 of its ownK072679 P.004 AbutmentsInstitut Straumann AG · 2007
Showing 5 of 535 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 535 · See all- K062129P.0004 ImplantsInstitut Straumann AG · 2006 · cites it directly434descendants
- K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · cites it directly376descendants
- K053088Slactive ImplantsInstitut Straumann AG · 2006 · 2 generations on295descendants
- K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007 · 2 generations on283descendants
- K072679P.004 AbutmentsInstitut Straumann AG · 2007 · 2 generations on279descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −1 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| 0 (this device) | K012757 | Iti Dental Implant System | Straumann USA | 2001 | — |
| +1 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| +1 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| +2 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| +2 | K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) | Straumann Manufacturing, Inc. | 2007 | — |
| +2 | K072679 | P.004 Abutments | Institut Straumann AG | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 13 | 0 |
| 2008 | 9 | 0 |
| 2009 | 7 | 0 |
| 2010 | 12 | 0 |
| 2011 | 11 | 0 |
| 2012 | 16 | 0 |
| 2013 | 21 | 0 |
| 2014 | 25 | 0 |
| 2015 | 31 | 0 |
| 2016 | 25 | 0 |
| 2017 | 28 | 0 |
| 2018 | 31 | 0 |
| 2019 | 23 | 0 |
| 2020 | 39 | 0 |
| 2021 | 35 | 0 |
| 2022 | 35 | 0 |
| 2023 | 53 | 0 |
| 2024 | 55 | 0 |
| 2025 | 36 | 0 |
| 2026 | 22 | 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 |
|---|---|---|---|
| * | K003271 | Modification to Iti Dental Implant SystemSummary page 1…Classification Name: Endosseous dental implants 21 CFR 872.3640 Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices ITI Self-Tapping Implants (K003271) ITI Temporary Abutment (K990342) Description of the Device The ITI tapered implant is an addition to the currently distributed… | 2001 |
| * | K990342 | Synocta ProstheticsSummary page 1…ental implants 21 CFR 872.3640 Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices ITI Self-Tapping Implants (K003271) ITI Temporary Abutment (K990342) Description of the Device The ITI tapered implant is an addition to the currently distributed ITI Dental Implant System. The t… | 1999 |
What descends from it? (535)
See all 53511 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062129 | P.0004 Implants | 2006 | 434 |
| K033984 | Straumann Dental Implant System | 2004 | 376 |
| K122855 | TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental Implants | 2012 | 123 |
| K123784 | Straumann Dental Implant System | 2013 | 122 |
| K061169 | Endosseous Dental Implant | 2006 | 24 |
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | 2015 | 6 |
| K151916 | TRI Dental Implant System | 2015 | 4 |
| K111798 | Sternic Implant 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM… | 2012 | 1 |
| K060062 | Straumann Orthosystem | 2006 | 1 |
| K082573 | Sargon Non-Expandable Dental Implant | 2010 | 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 11 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K062129 (Institut Straumann AG, 2006) has gone furthest, with 434 descendants of its own.
- 5 other devices also cite its predicate K003271.
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® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012757: 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/K012757
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026