510(k) · Cleared
ClearedET Iii SA Ultra Wide System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hiossen, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Mar 10, 2011 as substantially equivalent to K093889 (Hiossen, Inc., 2010) and 2 other predicates after a 98-day review. Its family tree reaches back 11 generations to 1990. 37 later devices descend from it.
- Decided
- Mar 10, 2011
- Review
- 98 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K894595 (1990). 37 ancestors in all. 37 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 1 generation backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- This deviceK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- Descendant · cites it directly · 24 of its ownK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
- Descendant · cites it directly · 13 of its ownK140934 Hiossen Implant SystemHiossen, Inc. · 2014
- Descendant · 2 generations on · 10 of its ownK153521 IH Implant SystemSewonmedix, Inc. · 2016
- Descendant · 2 generations on · 9 of its ownK151626 ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 7 of its ownK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 7 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 6 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 5 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 4 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 1 generation backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- This deviceK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K121995TS Fixture SystemOsstem Implant Co., Ltd. · 2012 · cites it directly24descendants
- K140934Hiossen Implant SystemHiossen, Inc. · 2014 · cites it directly13descendants
- K153521IH Implant SystemSewonmedix, Inc. · 2016 · 2 generations on10descendants
- K151626ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · 2 generations on9descendants
- K203360EK Implants and Abutments SystemHiossen, Inc. · 2022 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −7 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −6 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −5 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −4 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −2 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −1 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| 0 (this device) | K103537 | ET Iii SA Ultra Wide System | Hiossen, Inc. | 2011 | — |
| +1 | K121995 | TS Fixture System | Osstem Implant Co., Ltd. | 2012 | — |
| +1 | K140934 | Hiossen Implant System | Hiossen, Inc. | 2014 | — |
| +2 | K153521 | IH Implant System | Sewonmedix, Inc. | 2016 | — |
| +2 | K151626 | ET III Bio-SA Fixture System | Hiossen, Inc. | 2016 | 1 |
| +2 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
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 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K093889 | Modification to: HG Iii Ultra Wide SystemSummary page 1…Class 11 DZE 3. Predicate Device The HGIII Ultra wide Fixture System, Hiossen Inc, K093 889 The ETIII SA Fixture System, Hiossen Inc, K101096 The H-U/HS/HG Prosthetic System, Osstem Implant Co., Ltd, K081575… | 2010 |
| * | K101096 | HT Iii SA Fixture SystemSummary page 1…DZE 3. Predicate Device The HGIII Ultra wide Fixture System, Hiossen Inc, K093 889 The ETIII SA Fixture System, Hiossen Inc, K101096 The H-U/HS/HG Prosthetic System, Osstem Implant Co., Ltd, K081575 4. Description 1) The ETIII SA Ultra wide Fixture… | 2010 |
| * | K081575 | HU/HS/HG Prosthetic SystemSummary page 1…II Ultra wide Fixture System, Hiossen Inc, K093 889 The ETIII SA Fixture System, Hiossen Inc, K101096 The H-U/HS/HG Prosthetic System, Osstem Implant Co., Ltd, K081575 4. Description 1) The ETIII SA Ultra wide Fixture is dental implant made of titanium metal intended to be used in… | 2008 |
What descends from it? (37)
See all 372 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)
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 21 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 2 of the 37 ancestors have a recall of any class.
- Of its descendants, K121995 (Osstem Implant Co., Ltd., 2012) has gone furthest, with 24 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 ETIII SA Ultra wide System is indicated for use in partially or fully edentulous mandibles and maxillac, in support of single or mnultiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The ETIfi SA Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The ETIII SA Ultra wide Fixture System is intended to be used in thle molar region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103537 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103537: ET Iii SA Ultra Wide System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103537
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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