510(k) · Cleared
ClearedSynocta Angled Abutments for the Iti Wide Neck Implant
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 5, 2002 as substantially equivalent to K994119 (Straumann USA, 2000) after a 74-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 5, 2002
- Review
- 74 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K905434 (1992). 7 ancestors in all, the oldest K894844 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK905434 Angulated Abutment, Complete,Titanium Sdca 102Nobelpharma USA, Inc. · 1992
- 2 generations backK962647 Angled AbutmentStraumann USA · 1996
- 1 generation backK994119 Synocta Angled AbutmentsStraumann USA · 2000
- This deviceK013891 Synocta Angled Abutments for the Iti Wide Neck ImplantInstitut Straumann AG · 2002
- Descendant · cites it directly · 1 of its ownK061500 Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG · 2006
- Descendant · 2 generations on · 0 of its ownK073622 Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905434 | Angulated Abutment, Complete,Titanium Sdca 102 | Nobelpharma USA, Inc. | 1992 | — |
| −2 | K962647 | Angled Abutment | Straumann USA | 1996 | — |
| −1 | K994119 | Synocta Angled Abutments | Straumann USA | 2000 | — |
| 0 (this device) | K013891 | Synocta Angled Abutments for the Iti Wide Neck Implant | Institut Straumann AG | 2002 | — |
| +1 | K061500 | Sicace Dental Implant System and Sic Angled Abutments | Sic Invent AG | 2006 | — |
| +2 | K073622 | Easy Grip Dental Implant System | T.F.I. System S.R.L | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K994119 | Synocta Angled AbutmentsSummary page 1…ication Name: Endosseous dental implants 21 CFR 872.3640 3. Leqgally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI synOcta Angled Abutment (K994119) 4. Description of the Device The ITI Dental Implant System is an integrated system of endosseous dental implants which are des… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061500 | Sicace Dental Implant System and Sic Angled Abutments | 2006 | 1 |
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 10 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K061500 (Sic Invent AG, 2006) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K994119.
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 ITI synOcta angled abutments for Wide Neck Implants are indicated for use in cases where the placement of an implant requires an angled reconstruction for an optimal result. 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/K013891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013891: Synocta Angled Abutments for the Iti Wide Neck Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013891
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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