510(k) · Cleared
ClearedHG II Fixture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 17, 2008 as substantially equivalent to K063861 (Osstem Implant Co., Ltd., 2007) and 1 other predicate after a 122-day review. Its family tree reaches back 7 generations to 1990. 112 later devices descend from it.
- Decided
- Jul 17, 2008
- Review
- 122 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K894595 (1990). 18 ancestors in all. 112 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 4 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 3 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 2 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 1 generation backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- This deviceK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- Descendant · cites it directly · 110 of its ownK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- Descendant · 2 generations on · 105 of its ownK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- Descendant · 3 generations on · 104 of its ownK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- Descendant · 4 generations on · 75 of its ownK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- Descendant · 4 generations on · 64 of its ownK121585 TS Implant SystemOsstem Implant Co., Ltd. · 2013
Showing 5 of 112 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 112 · See all- K082213GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008 · cites it directly110descendants
- K093352HG Iii Fixture SystemHiossen, Inc. · 2009 · 2 generations on105descendants
- K101096HT Iii SA Fixture SystemHiossen, Inc. · 2010 · 3 generations on104descendants
- K120847ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012 · 4 generations on75descendants
- K121585TS Implant SystemOsstem Implant Co., Ltd. · 2013 · 4 generations on64descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −4 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −3 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −2 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −1 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| 0 (this device) | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| +1 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| +2 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| +3 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| +4 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| +4 | K121585 | TS Implant System | Osstem Implant Co., Ltd. | 2013 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K063861 | GS SystemSummary page 1…Class II DZE 3. Predicate Device: The GS System, Osstem Implant Co., Ltd, K063861 The OsseoSpeedTm , Astra tech Inc, K053384 4. Description: The HG II Fixture System is a dental implant made of titanium m… | 2007 |
| * | K053384 | Fixature Microthread Osseospeed, a Component of the Astra Tech Implant SystemSummary page 1…ss II DZE 3. Predicate Device: The GS System, Osstem Implant Co., Ltd, K063861 The OsseoSpeedTm , Astra tech Inc, K053384 4. Description: The HG II Fixture System is a dental implant made of titanium metal intended to be surgically placed in th… | 2006 |
What descends from it? (112)
See all 1122 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 18 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K082213 (Osstem Implant Co., Ltd., 2008) has gone furthest, with 110 descendants of its own.
- 9 other devices also cite its predicate K063861.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 HG II 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 HG II Fixture System is for single and two stage surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080744: HG II 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/K080744
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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