510(k) · Cleared
ClearedHU/HS/HG 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 Sep 2, 2008 as substantially equivalent to K062030 (Osstem Implant Co., Ltd., 2006) and 3 other predicates after an 89-day review. Its family tree reaches back 8 generations to 1990. 129 later devices descend from it.
- Decided
- Sep 2, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K894595 (1990). 19 ancestors in all. 129 later devices descend from it, 10 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 4 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 3 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 2 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 1 generation backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- This deviceK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- Descendant · cites it directly · 111 of its ownK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- Descendant · cites it directly · 105 of its ownK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- Descendant · cites it directly · 75 of its ownK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- Descendant · 2 generations on · 64 of its ownK121585 TS Implant SystemOsstem Implant Co., Ltd. · 2013
- Descendant · cites it directly · 54 of its ownK121843 NP-Cast Abutment SystemOsstem Implant Co., Ltd. · 2012
Showing 5 of 129 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 129 · See all- K100245HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010 · cites it directly111descendants
- K110308Prosthetic SystemOsstem Implant Co., Ltd. · 2011 · cites it directly105descendants
- K120847ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012 · cites it directly75descendants
- K121585TS Implant SystemOsstem Implant Co., Ltd. · 2013 · 2 generations on64descendants
- K121843NP-Cast Abutment SystemOsstem Implant Co., Ltd. · 2012 · cites it directly54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −4 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −3 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −2 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −1 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| 0 (this device) | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| +1 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| +1 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| +1 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| +2 | K121585 | TS Implant System | Osstem Implant Co., Ltd. | 2013 | — |
| +1 | K121843 | NP-Cast Abutment System | Osstem Implant Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 8 | 0 |
| 2017 | 10 | 0 |
| 2018 | 6 | 0 |
| 2019 | 2 | 0 |
| 2020 | 13 | 0 |
| 2021 | 12 | 0 |
| 2022 | 8 | 0 |
| 2023 | 22 | 0 |
| 2024 | 17 | 0 |
| 2025 | 7 | 0 |
| 2026 | 8 | 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? (4)
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 1…Class II NHA 3. Predicate Device The US System, Osstem Implant Co., Ltd, K062030 The SS System, Osstem Implant Co., Ltd, K062051 The GS System, Osstem Implant Co., Ltd, K063861 The US/SS/GS System, Oss… | 2006 |
| * | K062051 | SS SystemSummary page 1…I NHA 3. Predicate Device The US System, Osstem Implant Co., Ltd, K062030 The SS System, Osstem Implant Co., Ltd, K062051 The GS System, Osstem Implant Co., Ltd, K063861 The US/SS/GS System, Osstem Implant Co., Ltd, K073247 4. Description: Th… | 2006 |
| * | K063861 | GS SystemSummary page 1…NHA 3. Predicate Device The US System, Osstem Implant Co., Ltd, K062030 The SS System, Osstem Implant Co., Ltd, K062051 The GS System, Osstem Implant Co., Ltd, K063861 The US/SS/GS System, Osstem Implant Co., Ltd, K073247 4. Description: The HU/HS/HG Prosthetic System is device made of tita… | 2007 |
| * | K073247 | US/SS/GS SystemSummary page 1…Co., Ltd, K062030 The SS System, Osstem Implant Co., Ltd, K062051 The GS System, Osstem Implant Co., Ltd, K063861 The US/SS/GS System, Osstem Implant Co., Ltd, K073247 4. Description: The HU/HS/HG Prosthetic System is device made of titanium, titanium alloy, POM and PC intended for use as an… | 2008 |
What descends from it? (129)
See all 12910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100245 | HS/HG Prosthetic System | 2010 | 111 |
| K110308 | Prosthetic System | 2011 | 105 |
| K120847 | ET/SS Implant System | 2012 | 75 |
| K121843 | NP-Cast Abutment System | 2012 | 54 |
| K140507 | Hiossen Prosthetic System | 2014 | 44 |
| K103537 | ET Iii SA Ultra Wide System | 2011 | 37 |
| K160670 | ET US SS Prosthetic system | 2017 | 32 |
| K153521 | IH Implant System | 2016 | 10 |
| K172100 | URIS OMNI System | 2018 | 7 |
| K173141 | CSM Submerged3-L Implant System | 2018 | 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 18 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K100245 (Osstem Implant Co., Ltd., 2010) has gone furthest, with 111 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. 2008, 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?
HU/HS/HG 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/K081575 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081575: HU/HS/HG 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/K081575
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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