510(k) · Cleared
ClearedET II Bio-SA Fixture 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 Aug 6, 2012 as substantially equivalent to K101096 (Hiossen, Inc., 2010) and 2 other predicates after a 341-day review. Its family tree reaches back 11 generations to 1990. 10 later devices descend from it.
- Decided
- Aug 6, 2012
- Review
- 341 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K894595 (1990). 96 ancestors in all, the oldest K781060 (1978). 10 later devices descend from it, 1 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 deviceK112532 ET II Bio-SA Fixture SystemHiossen, Inc. · 2012
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 2 of its ownK221866 S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK253372 ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing…Hiossen, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK251427 EK Multi Angled 30 AbutmentHiossen, Inc. · 2026
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 deviceK112532 ET II Bio-SA Fixture SystemHiossen, Inc. · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151626ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · cites it directly9descendants
- K203360EK Implants and Abutments SystemHiossen, Inc. · 2022 · 2 generations on7descendants
- K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024 · 3 generations on2descendants
- K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc. · 2026 · 3 generations on0descendants
- K251427EK Multi Angled 30 AbutmentHiossen, Inc. · 2026 · 3 generations on0descendants
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) | K112532 | ET II Bio-SA Fixture System | Hiossen, Inc. | 2012 | — |
| +1 | K151626 | ET III Bio-SA Fixture System | Hiossen, Inc. | 2016 | 1 |
| +2 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| +3 | K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024 | — |
| +3 | K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | 2026 | — |
| +3 | 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 | 4 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K101096 | HT Iii SA Fixture SystemSummary page 1…FR872.3640 Class 11 DZE 3. Predicate Device The ETIIT SA Fixture System, HiOSSEN Inc, K 10 1096 The NanoTite PREVAIL Implant, Biomet 31 Inc, K072363 The Dio Biotite-H Implant System, DIO Department, DSI, Inc, K07307… | 2010 |
| * | K072363 | Nanotite Prevail,Certain,Parellel Walled,Tapered,External HexSummary page 1…DZE 3. Predicate Device The ETIIT SA Fixture System, HiOSSEN Inc, K 10 1096 The NanoTite PREVAIL Implant, Biomet 31 Inc, K072363 The Dio Biotite-H Implant System, DIO Department, DSI, Inc, K073070 4. Description: 1) The ETTII Bio-SA Fixture Syst… | 2008 |
| * | K073070 | Dio Biotite-H Implant SystemSummary page 1…TIIT SA Fixture System, HiOSSEN Inc, K 10 1096 The NanoTite PREVAIL Implant, Biomet 31 Inc, K072363 The Dio Biotite-H Implant System, DIO Department, DSI, Inc, K073070 4. Description: 1) The ETTII Bio-SA Fixture System is dental implant made of titanium metal intended to be surgica… | 2008 |
What descends from it? (10)
1 later device cites 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 |
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 22 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 9 of the 96 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. 2012, 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?
ETIII Bio-SA Fixture 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 terminal or intermediate abutment support for fixed bridgework. ETIII Bio-SA Fixture System is for single and two stage surgical procedures. It is intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112532: ET II Bio-SA Fixture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112532
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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