510(k) · Cleared
ClearedProsthetic 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 Oct 3, 2011 as substantially equivalent to K081575 (Osstem Implant Co., Ltd., 2008) and 1 other predicate after a 243-day review. Its family tree reaches back 10 generations to 1990. 105 later devices descend from it.
- Decided
- Oct 3, 2011
- Review
- 243 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K894595 (1990). 27 ancestors in all. 105 later devices descend from it, 7 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- This deviceK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- Descendant · cites it directly · 75 of its ownK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- Descendant · cites it directly · 47 of its ownK123755 Multi Angled AbutmentOsstem Implant Co., Ltd. · 2013
- Descendant · cites it directly · 44 of its ownK140507 Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014
- Descendant · cites it directly · 42 of its ownK130662 ET Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 38 of its ownK161689 OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd. · 2017 · Recalled
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 6 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 5 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 4 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 3 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- This deviceK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 105 · See all- K120847ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012 · cites it directly75descendants
- K123755Multi Angled AbutmentOsstem Implant Co., Ltd. · 2013 · cites it directly47descendants
- K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · cites it directly44descendants
- K130662ET Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · cites it directly42descendants
- K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd. · 2017 · 2 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −6 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −5 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −4 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −3 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −2 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −1 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| 0 (this device) | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| +1 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| +1 | K123755 | Multi Angled Abutment | Osstem Implant Co., Ltd. | 2013 | — |
| +1 | K140507 | Hiossen Prosthetic System | Osstem Implant Co., Ltd. | 2014 | — |
| +1 | K130662 | ET Prosthetic System | Osstem Implant Co., Ltd. | 2014 | 4 |
| +2 | K161689 | OSSTEM Implant System - Abutment | Osstem Implant Co., Ltd. | 2017 | 2 |
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 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 8 | 0 |
| 2017 | 10 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 7 | 0 |
| 2023 | 19 | 0 |
| 2024 | 15 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K081575 | HU/HS/HG Prosthetic SystemSummary page 1…Class I NHA 3. Predicate Device The HUll-S/HG Prosthetic System, Osstemn Implant Co., Ltd, K08 1575 The HS/HG Prosthetic System, Osstem. Implant Co., Ltd, K100245 4. Description: 1) The Prosthetic System is device made of… | 2008 |
| * | K100245 | HS/HG Prosthetic SystemSummary page 1…NHA 3. Predicate Device The HUll-S/HG Prosthetic System, Osstemn Implant Co., Ltd, K08 1575 The HS/HG Prosthetic System, Osstem. Implant Co., Ltd, K100245 4. Description: 1) The Prosthetic System is device made of titanium, titanium alloy, Gold alloy, POM and PC intended fo… | 2010 |
What descends from it? (105)
See all 1057 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 21 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K120847 (Osstem Implant Co., Ltd., 2012) has gone furthest, with 75 descendants of its own.
- 9 other devices also cite its predicate K081575.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
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/K110308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110308: Prosthetic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110308
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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