510(k) · Cleared
ClearedET US SS Prosthetic 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 Apr 25, 2017 as substantially equivalent to K062030 (Osstem Implant Co., Ltd., 2006) and 8 other predicates after a 411-day review. Its family tree reaches back 13 generations to 1990. 32 later devices descend from it.
- Decided
- Apr 25, 2017
- Review
- 411 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 13 generations to K894595 (1990). 74 ancestors in all, the oldest K894844 (1990). 32 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 2 generations backK123755 Multi Angled AbutmentOsstem Implant Co., Ltd. · 2013
- 1 generation backK132067 Multi Angled Abutment SystemHiossen, Inc. · 2013
- This deviceK160670 ET US SS Prosthetic systemOsstem 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 · 2 generations on · 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 · 2 generations on · 2 of its ownK233194 TS Abutment SystemOsstem Implant Co., Ltd. · 2024
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 backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 3 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 2 generations backK123755 Multi Angled AbutmentOsstem Implant Co., Ltd. · 2013
- 1 generation backK132067 Multi Angled Abutment SystemHiossen, Inc. · 2013
- This deviceK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · 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 · 2 generations on7descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · cites it directly6descendants
- K233194TS Abutment SystemOsstem Implant Co., Ltd. · 2024 · 2 generations on2descendants
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 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| −3 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| −2 | K123755 | Multi Angled Abutment | Osstem Implant Co., Ltd. | 2013 | — |
| −1 | K132067 | Multi Angled Abutment System | Hiossen, Inc. | 2013 | — |
| 0 (this device) | K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017 | — |
| +1 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| +2 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +2 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| +1 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +2 | K233194 | TS Abutment System | Osstem Implant Co., Ltd. | 2024 | — |
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 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 9 | 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 |
|---|---|---|---|
| * | K062030 | US SystemSummary page 4…FR872.3630 Device Classification: Class II Product Code: NHA 3. Predicate Device: Primary Predicate K062030 US System, OSSTEM IMPLANT CO.,LTD Reference Predicates K121585 TS Implant System, OSSTEM IMPLANT CO.,LTD K100245 HS, HG Pr… | 2006 |
| * | K121585 | TS Implant SystemSummary page 4…I Product Code: NHA 3. Predicate Device: Primary Predicate K062030 US System, OSSTEM IMPLANT CO.,LTD Reference Predicates K121585 TS Implant System, OSSTEM IMPLANT CO.,LTD K100245 HS, HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K130662 ET Prosthetic Syst… | 2013 |
| * | K100245 | HS/HG Prosthetic SystemSummary page 4…NHA 3. Predicate Device: Primary Predicate K062030 US System, OSSTEM IMPLANT CO.,LTD Reference Predicates K121585 TS Implant System, OSSTEM IMPLANT CO.,LTD K100245 HS, HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K130662 ET Prosthetic System, OSSTEM IMPLANT CO.,LTD K062051 SS System, OSST… | 2010 |
| * | K130662 | ET Prosthetic SystemSummary page 4…S System, OSSTEM IMPLANT CO.,LTD Reference Predicates K121585 TS Implant System, OSSTEM IMPLANT CO.,LTD K100245 HS, HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K130662 ET Prosthetic System, OSSTEM IMPLANT CO.,LTD K062051 SS System, OSSTEM IMPLANT CO.,LTD K073247 US.SS.GS System, OSSTEM IMPLAN… | 2014 |
| * | K062051 | SS SystemSummary page 4…s K121585 TS Implant System, OSSTEM IMPLANT CO.,LTD K100245 HS, HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K130662 ET Prosthetic System, OSSTEM IMPLANT CO.,LTD K062051 SS System, OSSTEM IMPLANT CO.,LTD K073247 US.SS.GS System, OSSTEM IMPLANT CO.,LTD K121843 NP Cast Abutment System, OSSTEM IMP… | 2006 |
| * | K073247 | US/SS/GS SystemSummary page 4…T CO.,LTD K100245 HS, HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K130662 ET Prosthetic System, OSSTEM IMPLANT CO.,LTD K062051 SS System, OSSTEM IMPLANT CO.,LTD K073247 US.SS.GS System, OSSTEM IMPLANT CO.,LTD K121843 NP Cast Abutment System, OSSTEM IMPLANT CO.,LTD K081575 HU.HS.HG Prosthetic S… | 2008 |
| * | K121843 | NP-Cast Abutment SystemSummary page 4…STEM IMPLANT CO.,LTD K130662 ET Prosthetic System, OSSTEM IMPLANT CO.,LTD K062051 SS System, OSSTEM IMPLANT CO.,LTD K073247 US.SS.GS System, OSSTEM IMPLANT CO.,LTD K121843 NP Cast Abutment System, OSSTEM IMPLANT CO.,LTD K081575 HU.HS.HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K132067 Multi An… | 2012 |
| * | K081575 | HU/HS/HG Prosthetic SystemSummary page 4…M IMPLANT CO.,LTD K062051 SS System, OSSTEM IMPLANT CO.,LTD K073247 US.SS.GS System, OSSTEM IMPLANT CO.,LTD K121843 NP Cast Abutment System, OSSTEM IMPLANT CO.,LTD K081575 HU.HS.HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K132067 Multi Angled Abutment with carrier, OSSTEM IMPLANT CO.,LTD… | 2008 |
| * | K132067 | Multi Angled Abutment SystemSummary page 4…K073247 US.SS.GS System, OSSTEM IMPLANT CO.,LTD K121843 NP Cast Abutment System, OSSTEM IMPLANT CO.,LTD K081575 HU.HS.HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K132067 Multi Angled Abutment with carrier, OSSTEM IMPLANT CO.,LTD ‐1/20‐… | 2013 |
| † | K072896 | GS Fixture System | 2007 |
What descends from it? (32)
See all 324 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 27 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 74 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.
- 9 other devices also cite its predicate K062030.
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?
ET System
The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
US/SS System
The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160670 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160670: ET US SS Prosthetic system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160670
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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