510(k) · Cleared
Recalled · Class II · 2025OSSTEM Implant System - Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 22, 2017 as substantially equivalent to K130662 (Osstem Implant Co., Ltd., 2014) and 4 other predicates after a 336-day review. Its family tree reaches back 13 generations to 1990. 38 later devices descend from it. It has been recalled 2 times.
- Decided
- May 22, 2017
- Review
- 336 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 13 generations to K894595 (1990). 67 ancestors in all, the oldest K894844 (1990). 38 later devices descend from it, 13 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 backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- 1 generation backK130662 ET Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · Recalled
- This deviceK161689 OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd. · 2017
- Descendant · cites it directly · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- Descendant · 2 generations on · 8 of its ownK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
- Descendant · cites it directly · 7 of its ownK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
- Descendant · cites it directly · 7 of its ownK172100 URIS OMNI SystemTruabutment, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
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 backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- 1 generation backK130662 ET Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · Recalled
- This deviceK161689 OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd. · 2017
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · cites it directly30descendants
- K211090ZENEX Implant SystemIzenimplant Co., Ltd. · 2022 · 2 generations on8descendants
- K203360EK Implants and Abutments SystemHiossen, Inc. · 2022 · cites it directly7descendants
- K172100URIS OMNI SystemTruabutment, Inc. · 2018 · cites it directly7descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · cites it directly6descendants
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 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| −1 | K130662 | ET Prosthetic System | Osstem Implant Co., Ltd. | 2014 | 4 |
| 0 (this device) | K161689 | OSSTEM Implant System - Abutment | Osstem Implant Co., Ltd. | 2017 | — |
| +1 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| +2 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +1 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| +1 | K172100 | URIS OMNI System | Truabutment, Inc. | 2018 | — |
| +1 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 4 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K130662 | ET Prosthetic SystemSummary page 4…lass II Subsequent Product Code: NHA 3. Predicate Device: Substantial equivalence is claimed to the following devices: Primary Predicate K130662, ET Prosthetic System, OSSTEM IMPLANT CO., LTD Reference predicate K120847, ET SS Implant System, OSSTEM IMPLANT CO., LTD… | 2014 |
| * | K081786 | Ziocera & Convertible SystemSummary page 4…devices: Primary Predicate K130662, ET Prosthetic System, OSSTEM IMPLANT CO., LTD Reference predicate K120847, ET SS Implant System, OSSTEM IMPLANT CO., LTD K081786, Ziocera & Convertible System, OSSTEM IMPLANT CO., LTD K121585, TS Implant System, OSSTEM IMPLANT CO., LTD K063861, GS System… | 2008 |
| * | K121585 | TS Implant SystemSummary page 4…SSTEM IMPLANT CO., LTD Reference predicate K120847, ET SS Implant System, OSSTEM IMPLANT CO., LTD K081786, Ziocera & Convertible System, OSSTEM IMPLANT CO., LTD K121585, TS Implant System, OSSTEM IMPLANT CO., LTD K063861, GS System, OSSTEM IMPLANT CO., LTD K110308, Prosthrtic System K100245,… | 2013 |
| * | K120847 | ET/SS Implant SystemSummary page 4…e: Substantial equivalence is claimed to the following devices: Primary Predicate K130662, ET Prosthetic System, OSSTEM IMPLANT CO., LTD Reference predicate K120847, ET SS Implant System, OSSTEM IMPLANT CO., LTD K081786, Ziocera & Convertible System, OSSTEM IMPLANT CO., LTD K121585, TS Imp… | 2012 |
| * | K100245 | HS/HG Prosthetic SystemSummary page 4…rtible System, OSSTEM IMPLANT CO., LTD K121585, TS Implant System, OSSTEM IMPLANT CO., LTD K063861, GS System, OSSTEM IMPLANT CO., LTD K110308, Prosthrtic System K100245, HS, HG Prosthetic System K140507, Hiossen Prosthetic system K062051, SS System 4. Description: The OSSTEM Implant System… | 2010 |
| † | K063861 | GS System | 2007 |
| † | K110308 | Prosthetic System | 2011 |
| † | K140507 | Hiossen Prosthetic System | 2014 |
| † | K062051 | SS System | 2006 |
What descends from it? (38)
See all 3813 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182091 | Osstem Abutment System | 2019 | 30 |
| K203360 | EK Implants and Abutments System | 2022 | 7 |
| K172100 | URIS OMNI System | 2018 | 7 |
| K200817 | URIS OMNI Narrow System & Prosthetic | 2020 | 6 |
| K233194 | TS Abutment System | 2024 | 2 |
| K231557 | ZENEX FreeMilling & CCM Cast Abutment | 2023 | 2 |
| K210903 | IS Multi Unit Abutment System | 2021 | 2 |
| K231395 | INNO SLA Submerged Narrow Implant System | 2023 | 1 |
| K251605 | DIMPLO Implant System | 2025 | 0 |
| K232528 | Protective Cap | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 27, 2025 | Class II | Z-1276-2025 | Under Investigation by firm | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual… |
| Jan 27, 2025 | Class II | Z-1274-2025 | Under Investigation by firm | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual… |
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 1.2 years on median.
- 4 of the 67 ancestors have a recall of any class.
- Of its descendants, K182091 (Osstem Implant Co., Ltd., 2019) has gone furthest, with 30 descendants of its own.
- 2 other devices also cite its predicate K130662.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161689 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161689: OSSTEM Implant System - Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161689
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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