510(k) · Cleared
ClearedHiossen Implant 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 Nov 12, 2014 as substantially equivalent to K101096 (Hiossen, Inc., 2010) and 6 other predicates after a 215-day review. Its family tree reaches back 12 generations to 1990. 13 later devices descend from it.
- Decided
- Nov 12, 2014
- Review
- 215 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K894595 (1990). 123 ancestors in all, the oldest K781060 (1978). 13 later devices descend from it, 6 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 2 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 1 generation backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- This deviceK140934 Hiossen Implant SystemHiossen, Inc. · 2014
- Descendant · cites it directly · 9 of its ownK151626 ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · Recalled
- Descendant · cites it directly · 7 of its ownK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK221866 S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253372 ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing…Hiossen, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251427 EK Multi Angled 30 AbutmentHiossen, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 8 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 7 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 6 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 5 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 2 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 1 generation backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- This deviceK140934 Hiossen Implant SystemHiossen, Inc. · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K151626ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · cites it directly9descendants
- K203360EK Implants and Abutments SystemHiossen, Inc. · 2022 · cites it directly7descendants
- K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024 · 2 generations on2descendants
- K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc. · 2026 · cites it directly0descendants
- K251427EK Multi Angled 30 AbutmentHiossen, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −8 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −7 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −6 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −5 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −2 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −1 | K103537 | ET Iii SA Ultra Wide System | Hiossen, Inc. | 2011 | — |
| 0 (this device) | K140934 | Hiossen Implant System | Hiossen, Inc. | 2014 | — |
| +1 | K151626 | ET III Bio-SA Fixture System | Hiossen, Inc. | 2016 | 1 |
| +1 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| +2 | K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024 | — |
| +1 | K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | 2026 | — |
| +2 | K251427 | EK Multi Angled 30 Abutment | Hiossen, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K101096 | HT Iii SA Fixture SystemSummary page 4…Class II DZE, NHA 3. Predicate Device : HT III SA FIXTURE SYSTEM, HIOSSEN Inc, K101096 ETII SA Fixture System, HiOSSEN Inc., K123471 ETIII SA Ultra Wide System, HiOSSEN Inc., K103537 TS Implant System, OSSTE… | 2010 |
| * | K123471 | Etii SA Fixture SystemSummary page 4…II DZE, NHA 3. Predicate Device : HT III SA FIXTURE SYSTEM, HIOSSEN Inc, K101096 ETII SA Fixture System, HiOSSEN Inc., K123471 ETIII SA Ultra Wide System, HiOSSEN Inc., K103537 TS Implant System, OSSTEM CO., LTD., K121585 HSII Short Fixture System… | 2013 |
| * | K103537 | ET Iii SA Ultra Wide SystemSummary page 4…HA 3. Predicate Device : HT III SA FIXTURE SYSTEM, HIOSSEN Inc, K101096 ETII SA Fixture System, HiOSSEN Inc., K123471 ETIII SA Ultra Wide System, HiOSSEN Inc., K103537 TS Implant System, OSSTEM CO., LTD., K121585 HSII Short Fixture System, OSSTEM CO., LTD., K083633 ET SS Implant System,… | 2011 |
| * | K121585 | TS Implant SystemSummary page 4…YSTEM, HIOSSEN Inc, K101096 ETII SA Fixture System, HiOSSEN Inc., K123471 ETIII SA Ultra Wide System, HiOSSEN Inc., K103537 TS Implant System, OSSTEM CO., LTD., K121585 HSII Short Fixture System, OSSTEM CO., LTD., K083633 ET SS Implant System, OSSTEM CO., LTD., K120847 3i OSSEOTITE® Certa… | 2013 |
| * | K083633 | HS II Short Fixture SystemSummary page 4…iOSSEN Inc., K123471 ETIII SA Ultra Wide System, HiOSSEN Inc., K103537 TS Implant System, OSSTEM CO., LTD., K121585 HSII Short Fixture System, OSSTEM CO., LTD., K083633 ET SS Implant System, OSSTEM CO., LTD., K120847 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc., K063341… | 2009 |
| * | K120847 | ET/SS Implant SystemSummary page 4…HiOSSEN Inc., K103537 TS Implant System, OSSTEM CO., LTD., K121585 HSII Short Fixture System, OSSTEM CO., LTD., K083633 ET SS Implant System, OSSTEM CO., LTD., K120847 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc., K063341 4. Description : 1) The HIOSSEN Implant Syst… | 2012 |
| * | K063341 | 3I Osseotite Certain Dental ImplantsSummary page 4…Short Fixture System, OSSTEM CO., LTD., K083633 ET SS Implant System, OSSTEM CO., LTD., K120847 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc., K063341 4. Description : 1) The HIOSSEN Implant System is similar to other commercially available products based on the inten… | 2007 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151626 | ET III Bio-SA Fixture System | 2016 | 9 |
| K203360 | EK Implants and Abutments System | 2022 | 7 |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | 2026 | 0 |
| K183242 | ET IV SA Dental Implants | 2019 | 0 |
| K161103 | US SA Implant System | 2017 | 0 |
| K153332 | ETIII SA Fixture System (O3.2mm) | 2016 | 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 24 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 11 of the 123 ancestors have a recall of any class.
- Of its descendants, K151626 (Hiossen, Inc., 2016) has gone furthest, with 9 descendants of its own.
- 6 other devices also cite its predicate K101096.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 HIOSSEN Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ETIII SA Ultra Wide Fixture is intended to be used in the molar region.
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/K140934 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140934: Hiossen Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140934
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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