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 Sep 8, 2022 as substantially equivalent to K182091 (Osstem Implant Co., Ltd., 2019) and 1 other predicate after a 90-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Sep 8, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K894595 (1990). 230 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK132067 Multi Angled Abutment SystemHiossen, Inc. · 2013
- 2 generations backK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- 1 generation backK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- This deviceK221684 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2022
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 12 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 11 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 10 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 9 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 8 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 7 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 6 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 5 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 4 generations backK123755 Multi Angled AbutmentOsstem Implant Co., Ltd. · 2013
- 3 generations backK132067 Multi Angled Abutment SystemHiossen, Inc. · 2013
- 2 generations backK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- 1 generation backK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- This deviceK221684 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −12 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −11 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −10 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −9 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −8 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −7 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −6 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| −5 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| −4 | K123755 | Multi Angled Abutment | Osstem Implant Co., Ltd. | 2013 | — |
| −3 | K132067 | Multi Angled Abutment System | Hiossen, Inc. | 2013 | — |
| −2 | K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017 | — |
| −1 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| 0 (this device) | K221684 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2022 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K182091 | Osstem Abutment SystemSummary page 4…72.3630 - Devce Classification : Class II - Classification Product Code : NHA 3. Predicated Device Primary Predicate K182091 Osstem Abutment System Reference Device K160670 ET US SS Prosthetic System, Osstem… | 2019 |
| * | K160670 | ET US SS Prosthetic systemSummary page 4…lassification Product Code : NHA 3. Predicated Device Primary Predicate K182091 Osstem Abutment System Reference Device K160670 ET US SS Prosthetic System, Osstem Implant Co., Ltd. 4. Indication for use The Osstem Abutment System is… | 2017 |
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 32 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 25 of the 230 ancestors have a recall of any class.
- 10 other devices also cite its predicate K182091.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Abutment 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/K221684 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221684: Osstem Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221684
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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