510(k) · Cleared
Recalled · 2005Esthetic Ease Abutments for the 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 Feb 8, 2002 as substantially equivalent to K990342 (Straumann USA, 1999) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1990. 516 later devices descend from it. It has been recalled once.
- Decided
- Feb 8, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K894844 (1990). 5 ancestors in all. 516 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 2 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 1 generation backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- This deviceK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002
- Descendant · cites it directly · 514 of its ownK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- Descendant · 2 generations on · 434 of its ownK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- Descendant · 2 generations on · 328 of its ownK041236 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- Descendant · 3 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- Descendant · 3 generations on · 313 of its ownK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
Showing 5 of 516 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 516 · See all- K033243Iti Synocta Meso AbutmentsStraumann USA · 2003 · cites it directly514descendants
- K062129P.0004 ImplantsInstitut Straumann AG · 2006 · 2 generations on434descendants
- K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 2 generations on328descendants
- K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 3 generations on327descendants
- K090069Procera Implant Bridge OverdentureNobel Biocare AB · 2009 · 3 generations on313descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −2 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −1 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| 0 (this device) | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | — |
| +1 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| +2 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| +2 | K041236 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| +3 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| +3 | K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | 2009 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 6 | 0 |
| 2009 | 11 | 0 |
| 2010 | 9 | 0 |
| 2011 | 11 | 0 |
| 2012 | 13 | 0 |
| 2013 | 14 | 0 |
| 2014 | 24 | 0 |
| 2015 | 26 | 0 |
| 2016 | 31 | 0 |
| 2017 | 28 | 0 |
| 2018 | 26 | 0 |
| 2019 | 24 | 0 |
| 2020 | 42 | 0 |
| 2021 | 33 | 0 |
| 2022 | 33 | 0 |
| 2023 | 51 | 0 |
| 2024 | 57 | 0 |
| 2025 | 33 | 0 |
| 2026 | 24 | 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 |
|---|---|---|---|
| * | K990342 | Synocta ProstheticsSummary page 1…nt Classification Name: Endosseous dental implants 21 CFR 872.3640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI synOcta Abutment (K990342) ITI Wide Neck Implant synOcta Abutment (K013798) 4. Description of the Device The IT| Dental Implant System is an integrated s… | 1999 |
| * | K013798 | Prosthetic Accessories to the Iti Dental Implant SystemSummary page 1…s 21 CFR 872.3640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI synOcta Abutment (K990342) ITI Wide Neck Implant synOcta Abutment (K013798) 4. Description of the Device The IT| Dental Implant System is an integrated system of endosseous dental imfiglfants which are d… | 2001 |
What descends from it? (516)
See all 5162 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2005 | Not classified | Z-0975-05 | Other | Basal screw is too short to adequately hold the dental abutment in the implant |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K033243 (Straumann USA, 2003) has gone furthest, with 514 descendants of its own.
- 13 other devices also cite its predicate K990342.
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?
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI Esthetic abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
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/K020096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020096: Esthetic Ease Abutments for the 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/K020096
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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