510(k) · Cleared
Recalled · Class II · 2025ET 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 Jan 10, 2014 as substantially equivalent to K110308 (Osstem Implant Co., Ltd., 2011) and 1 other predicate after a 304-day review. Its family tree reaches back 12 generations to 1990. 42 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 10, 2014
- Review
- 304 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 12 generations to K894595 (1990). 46 ancestors in all. 42 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 2 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 1 generation backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- This deviceK130662 ET Prosthetic SystemOsstem Implant Co., Ltd. · 2014
- Descendant · cites it directly · 38 of its ownK161689 OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd. · 2017 · Recalled
- Descendant · cites it directly · 32 of its ownK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- Descendant · 2 generations on · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- Descendant · 3 generations on · 8 of its ownK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
- Descendant · cites it directly · 8 of its ownK153015 Transfer & Angled AbutmentOsstem Implant Co., Ltd. · 2016
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 8 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 7 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 6 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 5 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 2 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 1 generation backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- This deviceK130662 ET Prosthetic SystemOsstem Implant Co., Ltd. · 2014
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd. · 2017 · cites it directly38descendants
- K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017 · cites it directly32descendants
- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · 2 generations on30descendants
- K211090ZENEX Implant SystemIzenimplant Co., Ltd. · 2022 · 3 generations on8descendants
- K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. · 2016 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −8 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −7 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −6 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −5 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −2 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −1 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| 0 (this device) | K130662 | ET Prosthetic System | Osstem Implant Co., Ltd. | 2014 | — |
| +1 | K161689 | OSSTEM Implant System - Abutment | Osstem Implant Co., Ltd. | 2017 | 2 |
| +1 | K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017 | — |
| +2 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| +3 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +1 | K153015 | Transfer & Angled Abutment | Osstem Implant Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 12 | 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 30.7 · 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? (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 |
|---|---|---|---|
| * | K110308 | Prosthetic SystemSummary page 1…21 CFR872.3630 Class 11 NHA 3. Predicate Device: Prosthetic System, K 110308, Osstem Implant Co., Ltd ET/SS Implant System, K 120847, Osstem Implant Co., Ltd 4. Description: I) The ET Prosthetic Sys… | 2011 |
| * | K120847 | ET/SS Implant SystemSummary page 1…Class 11 NHA 3. Predicate Device: Prosthetic System, K 110308, Osstem Implant Co., Ltd ET/SS Implant System, K 120847, Osstem Implant Co., Ltd 4. Description: I) The ET Prosthetic System is device made of titanium and titanium alloy intended… | 2012 |
What descends from it? (42)
See all 423 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 27, 2025 | Class II | Z-1275-2025 | 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-1271-2025 | 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-1273-2025 | 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-1272-2025 | 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 24 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 46 ancestors have a recall of any class.
- Of its descendants, K161689 (Osstem Implant Co., Ltd., 2017) has gone furthest, with 38 descendants of its own.
- 6 other devices also cite its predicate K110308.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130662 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130662: ET Prosthetic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130662
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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