510(k) · Cleared
Recalled · Class II · 2023ET III 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 Jul 21, 2016 as substantially equivalent to K112532 (Hiossen, Inc., 2012) and 2 other predicates after a 400-day review. Its family tree reaches back 13 generations to 1990. 9 later devices descend from it. It has been recalled once.
- Decided
- Jul 21, 2016
- Review
- 400 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 13 generations to K894595 (1990). 150 ancestors in all, the oldest K781060 (1978). 9 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 2 generations backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- 1 generation backK140934 Hiossen Implant SystemHiossen, Inc. · 2014
- This deviceK151626 ET III Bio-SA Fixture SystemHiossen, Inc. · 2016
- 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 · 2 generations on · 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
- Descendant · 3 generations on · 0 of its ownK243731 HEXIM Implant; Samwon General AbutmentsP&A USA · 2025
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 10 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 9 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 8 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 7 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 6 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 3 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 2 generations backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- 1 generation backK140934 Hiossen Implant SystemHiossen, Inc. · 2014
- This deviceK151626 ET III Bio-SA Fixture SystemHiossen, Inc. · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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 · 2 generations on0descendants
- K251427EK Multi Angled 30 AbutmentHiossen, Inc. · 2026 · 2 generations on0descendants
- K243731HEXIM Implant; Samwon General AbutmentsP&A USA · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −10 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −9 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −8 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −7 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −6 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −3 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −2 | K103537 | ET Iii SA Ultra Wide System | Hiossen, Inc. | 2011 | — |
| −1 | K140934 | Hiossen Implant System | Hiossen, Inc. | 2014 | — |
| 0 (this device) | K151626 | ET III Bio-SA Fixture System | Hiossen, Inc. | 2016 | — |
| +1 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| +2 | K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024 | — |
| +2 | 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 | — |
| +3 | K243731 | HEXIM Implant; Samwon General Abutments | P&A USA | 2025 | — |
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 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 10 | 0 |
| 2003 | 9 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K112532 | ET II Bio-SA Fixture SystemSummary page 4…Class II DZE 3. Predicate Device : 1)Primary Predicate : ETIII Bio-SA Fixture System / HIOSSEN INC. / K112532 2)Reference Predicate : HIOSSEN Implant System / HIOSSEN INC. / K140934 3)Reference Predicate : SLActive / Straumann USA /… | 2012 |
| * | K140934 | Hiossen Implant SystemSummary page 4…E 3. Predicate Device : 1)Primary Predicate : ETIII Bio-SA Fixture System / HIOSSEN INC. / K112532 2)Reference Predicate : HIOSSEN Implant System / HIOSSEN INC. / K140934 3)Reference Predicate : SLActive / Straumann USA / K053088 4. Description : 1) Indication for use same as the primary pr… | 2014 |
| * | K053088 | Slactive ImplantsSummary page 4…Fixture System / HIOSSEN INC. / K112532 2)Reference Predicate : HIOSSEN Implant System / HIOSSEN INC. / K140934 3)Reference Predicate : SLActive / Straumann USA / K053088 4. Description : 1) Indication for use same as the primary predicate device, K112532 ETIII Bio-SA Fixture System is… | 2006 |
| † | K123784 | Straumann Dental Implant System | 2013 |
What descends from it? (9)
2 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 |
|---|---|---|---|---|
| Apr 6, 2023 | Class II | Z-1604-2023 | Labeling Change Control | Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 11 of the 150 ancestors have a recall of any class.
- Of its descendants, K203360 (Hiossen, Inc., 2022) has gone furthest, with 7 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. 2016, 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. The 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/K151626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151626: ET III 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/K151626
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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