510(k) · Cleared
ClearedHG Iii 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 Nov 24, 2009 as substantially equivalent to K082213 (Osstem Implant Co., Ltd., 2008) after a 28-day review. Its family tree reaches back 9 generations to 1990. 105 later devices descend from it.
- Decided
- Nov 24, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894595 (1990). 20 ancestors in all. 105 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- This deviceK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- Descendant · cites it directly · 104 of its ownK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- Descendant · 2 generations on · 75 of its ownK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- Descendant · 2 generations on · 64 of its ownK121585 TS Implant SystemOsstem Implant Co., Ltd. · 2013
- Descendant · 3 generations on · 44 of its ownK140507 Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014
- Descendant · 3 generations on · 42 of its ownK130662 ET Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · Recalled
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 5 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 4 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- This deviceK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 105 · See all- K101096HT Iii SA Fixture SystemHiossen, Inc. · 2010 · cites it directly104descendants
- K120847ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012 · 2 generations on75descendants
- K121585TS Implant SystemOsstem Implant Co., Ltd. · 2013 · 2 generations on64descendants
- K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · 3 generations on44descendants
- K130662ET Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · 3 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −5 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −4 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −3 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −2 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −1 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| 0 (this device) | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| +1 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| +2 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| +2 | K121585 | TS Implant System | Osstem Implant Co., Ltd. | 2013 | — |
| +3 | K140507 | Hiossen Prosthetic System | Osstem Implant Co., Ltd. | 2014 | — |
| +3 | K130662 | ET Prosthetic System | Osstem Implant Co., Ltd. | 2014 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 7 | 0 |
| 2017 | 9 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 9 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 20 | 0 |
| 2024 | 15 | 0 |
| 2025 | 6 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K082213 | GS Iii Fixture SystemSummary page 1…Class II DZE 3. Predicate Device: The HGIII Fixture System, HiOSSEN Inc, K082213 4. Description: The HGIIr Fixture System is dental implant made of titanium metal intended to be surgically placed in t… | 2008 |
What descends from it? (105)
See all 1051 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101096 | HT Iii SA Fixture System | 2010 | 104 |
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 19 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K101096 (Hiossen, Inc., 2010) has gone furthest, with 104 descendants of its own.
- 2 other devices also cite its predicate K082213.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 HGIII 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 HGIII Fixture System is for single and two stage surgical procedures. It is not for immediate load.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093352: HG Iii 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/K093352
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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