510(k) · Cleared
Recalled · 2012Modification to Iti Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · DZE Implant, Endosseous, Root-Form
Cleared on Jan 7, 2004 as substantially equivalent to K983742 (Institut Straumann AG, 1999) and 1 other predicate after a 20-day review. Its family tree reaches back 3 generations to 1990. 346 later devices descend from it. It has been recalled once.
- Decided
- Jan 7, 2004
- Review
- 20 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K894595 (1990). 16 ancestors in all. 346 later devices descend from it, 10 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 deviceK033922 Modification to Iti Dental Implant SystemInstitut Straumann AG · 2004
- Descendant · cites it directly · 181 of its ownK101207 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2010
- Descendant · cites it directly · 180 of its ownK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- Descendant · cites it directly · 148 of its ownK061176 Straumann Dental ImplantsInstitut Straumann AG · 2006
- Descendant · 2 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- Descendant · 2 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
Showing 5 of 346 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 346 · See all- K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2010 · cites it directly181descendants
- K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · cites it directly180descendants
- K061176Straumann Dental ImplantsInstitut Straumann AG · 2006 · cites it directly148descendants
- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 2 generations on127descendants
- K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 2 generations on123descendants
View 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) | K033922 | Modification to Iti Dental Implant System | Institut Straumann AG | 2004 | — |
| +1 | K101207 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2010 | — |
| +1 | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| +1 | K061176 | Straumann Dental Implants | Institut Straumann AG | 2006 | — |
| +2 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| +2 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 9 | 0 |
| 2014 | 12 | 0 |
| 2015 | 14 | 0 |
| 2016 | 12 | 0 |
| 2017 | 18 | 0 |
| 2018 | 13 | 0 |
| 2019 | 18 | 0 |
| 2020 | 29 | 0 |
| 2021 | 30 | 0 |
| 2022 | 29 | 0 |
| 2023 | 48 | 0 |
| 2024 | 42 | 0 |
| 2025 | 34 | 0 |
| 2026 | 23 | 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 |
|---|---|---|---|
| * | K983742 | Iti Dental Implant SystemSummary page 1…21 CFR 872.3640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI Esthetic PLUS Solid Screw Implants (K983742 and K030007) 4. Description of the Device The ITI Standard PLUS implants are modifications of the currently distribute… | 1999 |
| * | K030007 | Iti Dental Implant SystemSummary page 1…R 872.3640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI Esthetic PLUS Solid Screw Implants (K983742 and K030007) 4. Description of the Device The ITI Standard PLUS implants are modifications of the currently distributed ITI… | 2003 |
What descends from it? (346)
See all 34610 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101207 | Neodent Implant System | 2010 | 181 |
| K101945 | Neodent Implant System | 2011 | 180 |
| K061176 | Straumann Dental Implants | 2006 | 148 |
| 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 |
| K130222 | Straumann Dental Implant System | 2013 | 118 |
| K083633 | HS II Short Fixture System | 2009 | 76 |
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | 2015 | 6 |
| K133733 | WINSIX Implant System | 2015 | 0 |
| K073622 | Easy Grip Dental Implant System | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 12, 2012 | Not classified | Z-1351-2012 | Packaging process control | Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K101207 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2010) has gone furthest, with 181 descendants of its own.
- 6 other devices also cite its predicate K983742.
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. ITI Dental Implants are for single-stage or two-stage surgery.
ITI Dental Implants are intended for immediate placement and function on single-tooth
and/or multiple tooth applications when good primary stability is achieved, with
appropriate occlusal loading, in order to restore chewing function. Multiple tooth
applications may be rigidly splinted. In the case of edentulous patients, four or more
implants must be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033922 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033922: Modification to Iti Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033922
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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