510(k) · Cleared
ClearedNP-Cast 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 Dec 11, 2012 as substantially equivalent to K112045 (Dentium Co., Ltd., 2012) and 1 other predicate after a 169-day review. Its family tree reaches back 9 generations to 1990. 54 later devices descend from it.
- Decided
- Dec 11, 2012
- Review
- 169 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K894595 (1990). 25 ancestors in all. 54 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- This deviceK121843 NP-Cast Abutment SystemOsstem Implant Co., Ltd. · 2012
- Descendant · cites it directly · 44 of its ownK140507 Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014
- 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 · 2 generations on · 10 of its ownK153521 IH Implant SystemSewonmedix, Inc. · 2016
- Descendant · 3 generations on · 8 of its ownK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 5 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 4 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- This deviceK121843 NP-Cast Abutment SystemOsstem Implant Co., Ltd. · 2012
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · cites it directly44descendants
- K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017 · cites it directly32descendants
- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · 2 generations on30descendants
- K153521IH Implant SystemSewonmedix, Inc. · 2016 · 2 generations on10descendants
- K211090ZENEX Implant SystemIzenimplant Co., Ltd. · 2022 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −5 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −4 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −3 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −2 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −1 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| 0 (this device) | K121843 | NP-Cast Abutment System | Osstem Implant Co., Ltd. | 2012 | — |
| +1 | K140507 | Hiossen Prosthetic System | Osstem Implant Co., Ltd. | 2014 | — |
| +1 | K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017 | — |
| +2 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| +2 | K153521 | IH Implant System | Sewonmedix, Inc. | 2016 | — |
| +3 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 13 | 0 |
| 2024 | 9 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112045 | Simpleline II Abutment SystemSummary page 2…performance characteristics. 3) The NP-Cast Abutment System is substantially equivalent in design, function and intended use to The SimpleLine 11 Abutment System(K1 12045) of Dentium Co., Ltd. and Prosthetic System (Ki 10308) of OSSTEM Implant Co., Ltd., HU.HS.HG Prosthetic System (K081575… | 2012 |
| Kept off the family tree | K103308 | FDA’s K103308 is Aida HD Connect with Smartscreen / Blu-Ray Drive / Smartscreen with Blu-Ray… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
| * | K081575 | HU/HS/HG Prosthetic SystemSummary page 1…pleLine II Abutment System, Dentiumn Co., Ltd., KI 12045 Prosthetic System, OSSTEM Implant Co., Ltd., K 10308 HUJJS.HG Prosthetic System, OSSTEM Implant Co., Ltd., K081575 4. Description:I NP-Cast Abutment System is used for prosthetic restoration. It is used for cases with path and aesthetic… | 2008 |
What descends from it? (54)
See all 544 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 22 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K140507 (Osstem Implant Co., Ltd., 2014) has gone furthest, with 44 descendants of its own.
- 4 other devices also cite its predicate K112045.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
NP-Cast 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/K121843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121843: NP-Cast 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/K121843
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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