510(k) · Cleared
ClearedUS/GS Ultra Wide 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 Apr 7, 2008 as substantially equivalent to K062030 (Osstem Implant Co., Ltd., 2006) and 1 other predicate after a 119-day review. Its family tree reaches back 7 generations to 1990. 90 later devices descend from it.
- Decided
- Apr 7, 2008
- Review
- 119 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. 90 later devices descend from it, 4 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 deviceK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- Descendant · cites it directly · 55 of its ownK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- Descendant · cites it directly · 38 of its ownK093889 Modification to: HG Iii Ultra Wide SystemHiossen, Inc. · 2010
- Descendant · 2 generations on · 37 of its ownK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- Descendant · 2 generations on · 34 of its ownK113554 Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012
- Descendant · 3 generations on · 24 of its ownK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
Showing 5 of 90 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 90 · See all- K090825SQ IS SystemNeobiotech Co., Ltd. · 2009 · cites it directly55descendants
- K093889Modification to: HG Iii Ultra Wide SystemHiossen, Inc. · 2010 · cites it directly38descendants
- K103537ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011 · 2 generations on37descendants
- K113554Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012 · 2 generations on34descendants
- K121995TS Fixture SystemOsstem Implant Co., Ltd. · 2012 · 3 generations on24descendants
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) | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| +1 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| +1 | K093889 | Modification to: HG Iii Ultra Wide System | Hiossen, Inc. | 2010 | — |
| +2 | K103537 | ET Iii SA Ultra Wide System | Hiossen, Inc. | 2011 | — |
| +2 | K113554 | Cmi Implant IS System | Neobiotech Co., Ltd. | 2012 | — |
| +3 | K121995 | TS Fixture System | Osstem Implant Co., Ltd. | 2012 | — |
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 |
|---|---|---|
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 7 | 0 |
| 2019 | 3 | 0 |
| 2020 | 9 | 0 |
| 2021 | 2 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 11 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K062030 | US SystemSummary page 1…Class II DZE 3. Predicate Device: The US System, Osstem Implant Co., Ltd, K062030 The GS System, Osstem Implant Co., Ltd, K063861 4. Description: The US/GS Ultra Wide System is a dental implan… | 2006 |
| * | K063861 | GS SystemSummary page 1…DZE 3. Predicate Device: The US System, Osstem Implant Co., Ltd, K062030 The GS System, Osstem Implant Co., Ltd, K063861 4. Description: The US/GS Ultra Wide System is a dental implant made of titanium metal intended to be surgically… | 2007 |
What descends from it? (90)
See all 904 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, K090825 (Neobiotech Co., Ltd., 2009) has gone furthest, with 55 descendants of its own.
- 9 other devices also cite its predicate K062030.
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 US/GS Ultra Wide 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 US/GS Ultra Wide System is for single and two stage surgical procedures. It is not for immediate load. The US/GS Ultra Wide System is intended to be used in the molar reoion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073465: US/GS Ultra Wide System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073465
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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