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 Mar 31, 2003 as substantially equivalent to K984104 (Straumann USA, 1999) and 2 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1990. 570 later devices descend from it.
- Decided
- Mar 31, 2003
- Review
- 89 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K894595 (1990). 11 ancestors in all. 570 later devices descend from it, 12 citing it directly.
- Root · 2 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 1 generation backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- This deviceK030007 Iti Dental Implant SystemStraumann USA · 2003
- Descendant · cites it directly · 376 of its ownK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- Descendant · cites it directly · 346 of its ownK033922 Modification to Iti Dental Implant SystemInstitut Straumann AG · 2004 · Recalled
- Descendant · 2 generations on · 295 of its ownK053088 Slactive ImplantsInstitut Straumann AG · 2006
- Descendant · 3 generations on · 228 of its ownK083550 Straumann Dental Implant SystemStraumann USA · 2009
- Descendant · cites it directly · 228 of its ownK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
Showing 5 of 570 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 570 · See all- K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · cites it directly376descendants
- K033922Modification to Iti Dental Implant SystemInstitut Straumann AG · 2004 · cites it directly346descendants
- K053088Slactive ImplantsInstitut Straumann AG · 2006 · 2 generations on295descendants
- K083550Straumann Dental Implant SystemStraumann USA · 2009 · 3 generations on228descendants
- K060958Straumann Narrow Neck ImplantsStraumann USA · 2006 · cites it directly228descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −1 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| 0 (this device) | K030007 | Iti Dental Implant System | Straumann USA | 2003 | — |
| +1 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| +1 | K033922 | Modification to Iti Dental Implant System | Institut Straumann AG | 2004 | 1 |
| +2 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| +3 | K083550 | Straumann Dental Implant System | Straumann USA | 2009 | — |
| +1 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 5 | 0 |
| 2010 | 10 | 0 |
| 2011 | 7 | 0 |
| 2012 | 19 | 0 |
| 2013 | 22 | 0 |
| 2014 | 22 | 0 |
| 2015 | 27 | 0 |
| 2016 | 21 | 0 |
| 2017 | 33 | 0 |
| 2018 | 33 | 0 |
| 2019 | 28 | 0 |
| 2020 | 41 | 0 |
| 2021 | 45 | 0 |
| 2022 | 40 | 0 |
| 2023 | 61 | 0 |
| 2024 | 59 | 0 |
| 2025 | 43 | 0 |
| 2026 | 26 | 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? (3)
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 |
|---|---|---|---|
| * | K984104 | Iti Dental Implant SystemSummary page 1…21 CFR 872.3640 3. Leqallv Marketed Devices to which Equivalence is Claimed (Predicate Devices) IT1 Dental Implant System (K984104, K003552) Various Branemark System Implants (K022562) 4. Description of the Device IT1 solid screw imp… | 1999 |
| * | K003552 | Iti Dental Implant SystemSummary page 1…21 CFR 872.3640 3. Leqallv Marketed Devices to which Equivalence is Claimed (Predicate Devices) IT1 Dental Implant System (K984104, K003552) Various Branemark System Implants (K022562) 4. Description of the Device IT1 solid screw implants hav… | 2001 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 1…ed Devices to which Equivalence is Claimed (Predicate Devices) IT1 Dental Implant System (K984104, K003552) Various Branemark System Implants (K022562) 4. Description of the Device IT1 solid screw implants have an external spiral screw thread and an anchorage… | 2002 |
What descends from it? (570)
See all 57012 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033984 | Straumann Dental Implant System | 2004 | 376 |
| K033922 | Modification to Iti Dental Implant System | 2004 | 346 |
| K060958 | Straumann Narrow Neck Implants | 2006 | 228 |
| K040807 | Mis Dental Implant System | 2004 | 218 |
| K061176 | Straumann Dental Implants | 2006 | 148 |
| K033171 | Nsi Hexed and Non-Hexed Implant System and Immediate Loading | 2004 | 32 |
| K130572 | Interactive/ SWISHPLUS2 Implant System | 2013 | 10 |
| K034014 | Spi Contact Dental Implant | 2004 | 3 |
| K131097 | LEGACY3 6MM Length Implants | 2013 | 0 |
| K090709 | Cortex Dental Implant System | 2009 | 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 13 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K033984 (Institut Straumann AG, 2004) has gone furthest, with 376 descendants of its own.
- 9 other devices also cite its predicate K984104.
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 IT1 dental implants are 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 4 or more implants must be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030007: 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/K030007
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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