510(k) · Cleared
ClearedOsstem Abutment System
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 Jul 12, 2019 as substantially equivalent to K161689 (Osstem Implant Co., Ltd., 2017) and 8 other predicates after a 343-day review. Its family tree reaches back 14 generations to 1990. 30 later devices descend from it.
- Decided
- Jul 12, 2019
- Review
- 343 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 14 generations to K894595 (1990). 229 ancestors in all, the oldest K781060 (1978). 30 later devices descend from it, 11 citing it directly.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK123755 Multi Angled AbutmentOsstem Implant Co., Ltd. · 2013
- 2 generations backK132067 Multi Angled Abutment SystemHiossen, Inc. · 2013
- 1 generation backK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- This deviceK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- Descendant · cites it directly · 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 · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK233194 TS Abutment SystemOsstem Implant Co., Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK221866 S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 11 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 10 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 9 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 8 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 7 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 6 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 4 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 3 generations backK123755 Multi Angled AbutmentOsstem Implant Co., Ltd. · 2013
- 2 generations backK132067 Multi Angled Abutment SystemHiossen, Inc. · 2013
- 1 generation backK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- This deviceK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K211090ZENEX Implant SystemIzenimplant Co., Ltd. · 2022 · cites it directly8descendants
- K203360EK Implants and Abutments SystemHiossen, Inc. · 2022 · cites it directly7descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · cites it directly6descendants
- K233194TS Abutment SystemOsstem Implant Co., Ltd. · 2024 · cites it directly2descendants
- K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −11 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −10 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −9 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −8 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −7 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −6 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| −4 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| −3 | K123755 | Multi Angled Abutment | Osstem Implant Co., Ltd. | 2013 | — |
| −2 | K132067 | Multi Angled Abutment System | Hiossen, Inc. | 2013 | — |
| −1 | K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017 | — |
| 0 (this device) | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| +1 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +1 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| +1 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +1 | K233194 | TS Abutment System | Osstem Implant Co., Ltd. | 2024 | — |
| +1 | K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024 | — |
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 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 12 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 14 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 10 | 0 |
| 2000 | 5 | 0 |
| 2001 | 10 | 0 |
| 2002 | 17 | 0 |
| 2003 | 13 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 8 | 0 |
| 2007 | 12 | 0 |
| 2008 | 10 | 0 |
| 2009 | 5 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 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? (9)
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 |
|---|---|---|---|
| * | K161689 | OSSTEM Implant System - AbutmentSummary page 4…21 CFR 872.3630 Device Classification Class II Product Code NHA 3. Predicate Device Primary Predicate K161689 OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. Reference Predicates K160670… | 2017 |
| * | K120847 | ET/SS Implant SystemSummary page 4…Hiossen Prosthetic System, Osstem Implant Co., Ltd. K132067 Multi Angled Abutment System, Osstem Implant Co., Ltd. K120847 ET/SS Implant System, Osstem Implant Co., Ltd. K080594 MS System (Narrow R… | 2012 |
| * | K140507 | Hiossen Prosthetic SystemSummary page 4…em K160519 Link Abutment for CEREC, Osstem Implant Co., Ltd. K150295 LOCATOR RTx, Zest Anchors, Inc. K140507 Hiossen Prosthetic System, Osstem Implant Co., Ltd. K132067 Multi Angled A… | 2014 |
| * | K063861 | GS SystemSummary page 4…7 ET/SS Implant System, Osstem Implant Co., Ltd. K080594 MS System (Narrow Ridge), Osstem Implant Co., Ltd. K063861 GS System, Osstem Implant Co., Ltd. K062030 US System, Osstem Implant Co.,… | 2007 |
| * | K150295 | LOCATOR RTxSummary page 4…dicates K160670 ET US SS Prosthetic System K160519 Link Abutment for CEREC, Osstem Implant Co., Ltd. K150295 LOCATOR RTx, Zest Anchors, Inc. K140507 Hiossen Prosthetic System, Osstem… | 2015 |
| * | K132067 | Multi Angled Abutment SystemSummary page 4…K150295 LOCATOR RTx, Zest Anchors, Inc. K140507 Hiossen Prosthetic System, Osstem Implant Co., Ltd. K132067 Multi Angled Abutment System, Osstem Implant Co., Ltd. K120847 ET/SS Impla… | 2013 |
| * | K062030 | US SystemSummary page 4…K080594 MS System (Narrow Ridge), Osstem Implant Co., Ltd. K063861 GS System, Osstem Implant Co., Ltd. K062030 US System, Osstem Implant Co., Ltd. QS-QI-505-7(Rev.0) - 1 / 26 -… | 2006 |
| * | K160670 | ET US SS Prosthetic systemSummary page 4…te Device Primary Predicate K161689 OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. Reference Predicates K160670 ET US SS Prosthetic System K160519 Link Abutment for CEREC, Osstem Implant… | 2017 |
| * | K080594 | MS System (Narrow Ridge)Summary page 4…Multi Angled Abutment System, Osstem Implant Co., Ltd. K120847 ET/SS Implant System, Osstem Implant Co., Ltd. K080594 MS System (Narrow Ridge), Osstem Implant Co., Ltd. K063861 GS System, Osst… | 2008 |
| † | K160519 | Link Abutment for CEREC | 2016 |
What descends from it? (30)
See all 3011 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211090 | ZENEX Implant System | 2022 | 8 |
| K203360 | EK Implants and Abutments System | 2022 | 7 |
| K200817 | URIS OMNI Narrow System & Prosthetic | 2020 | 6 |
| K233194 | TS Abutment System | 2024 | 2 |
| K221866 | S-Plant Dental Implant System | 2024 | 2 |
| K232560 | Angled Abutment | 2023 | 1 |
| K251427 | EK Multi Angled 30 Abutment | 2026 | 0 |
| K231429 | S-Plant Dental Implant System | 2023 | 0 |
| K222636 | ET Abutment System | 2023 | 0 |
| K221684 | Osstem Abutment System | 2022 | 0 |
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 29 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 25 of the 229 ancestors have a recall of any class.
- Of its descendants, K211090 (Izenimplant Co., Ltd., 2022) has gone furthest, with 8 descendants of its own.
- 12 other devices also cite its predicate K161689.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. • Link Abutment for CEREC The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.…
Read the full statement (136 words)
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Link Abutment for CEREC
The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182091: Osstem Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182091
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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