510(k) · Cleared
ClearedUS SA Implant 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 Feb 2, 2017 as substantially equivalent to K080387 (Osstem Implant Co., Ltd., 2008) and 3 other predicates after a 289-day review. Its family tree reaches back 13 generations to 1990.
- Decided
- Feb 2, 2017
- Review
- 289 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K894595 (1990). 127 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- 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 backK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
- This deviceK161103 US SA Implant SystemOsstem Implant Co., Ltd. · 2017
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 backK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
- This deviceK161103 US SA Implant SystemOsstem Implant Co., Ltd. · 2017
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 | K121995 | TS Fixture System | Osstem Implant Co., Ltd. | 2012 | — |
| 0 (this device) | K161103 | US SA Implant System | Osstem Implant Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K080387 | HU II / HS II Fixture SystemSummary page 4…Class II Product Code: DZE, NHA 3. Predicate Device : - Primary predicate HU II / HS II FIXTURE SYSTEM, HiOSSEN Inc, K080387 - Reference predicate Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755 TS Fixture System, OSSTEM Implant… | 2008 |
| * | K121995 | TS Fixture SystemSummary page 4…SYSTEM, HiOSSEN Inc, K080387 - Reference predicate Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755 TS Fixture System, OSSTEM Implant Co., Ltd., K121995 US.SS.GS System, OSSTEM Implant Co., Ltd., K073247 3i OSSEOTITE Dental Implants, Implant Innovations, Inc, K063286… | 2012 |
| * | K123755 | Multi Angled AbutmentSummary page 4…vice : - Primary predicate HU II / HS II FIXTURE SYSTEM, HiOSSEN Inc, K080387 - Reference predicate Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755 TS Fixture System, OSSTEM Implant Co., Ltd., K121995 US.SS.GS System, OSSTEM Implant Co., Ltd., K073247 3i OSSE… | 2013 |
| * | K140934 | Hiossen Implant SystemSummary page 4…US.SS.GS System, OSSTEM Implant Co., Ltd., K073247 3i OSSEOTITE Dental Implants, Implant Innovations, Inc, K063286 HIOSSEN Implant System, HIOSSEN Inc., K140934 4. Description : The US SA Implant System is a dental implant made of titanium metal intended to be surgically placed in th… | 2014 |
| † | K073247 | US/SS/GS System | 2008 |
| † | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 11 of the 127 ancestors have a recall of any class.
- 2 other devices also cite its predicate K080387.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 SA Implant 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as bridges, or overdenture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161103: US SA Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161103
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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