510(k) · Cleared
ClearedTS Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 7, 2013 as substantially equivalent to K091678 (Osstem Implant Co., Ltd., 2010) and 4 other predicates after a 221-day review. Its family tree reaches back 11 generations to 1990. 64 later devices descend from it.
- Decided
- Jan 7, 2013
- Review
- 221 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K894595 (1990). 61 ancestors in all, the oldest K894844 (1990). 64 later devices descend from it, 8 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 1 generation backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- This deviceK121585 TS Implant SystemOsstem Implant Co., Ltd. · 2013
- Descendant · cites it directly · 44 of its ownK140507 Hiossen 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 · cites it directly · 13 of its ownK140934 Hiossen Implant SystemHiossen, Inc. · 2014
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 7 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 6 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 5 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 4 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 1 generation backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- This deviceK121585 TS Implant SystemOsstem Implant Co., Ltd. · 2013
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · cites it directly44descendants
- 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
- K140934Hiossen Implant SystemHiossen, Inc. · 2014 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −7 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −6 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −5 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −4 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −2 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −1 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| 0 (this device) | K121585 | TS Implant System | Osstem Implant Co., Ltd. | 2013 | — |
| +1 | K140507 | Hiossen 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 | — |
| +1 | K140934 | Hiossen Implant System | Hiossen, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2010 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 15 | 0 |
| 2024 | 12 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K091678 | HG II Short Fixture SystemSummary page 1…Class 11 DZE 3. Predicate Device: The HGII Short Fixture System, Osstem Implant Co., Ltd, K091678 The FuJII SA Fixture System, HIOSSEN Inc., K101096 The HS/HG Prosthetic System, Osstem Implant Co., Ltd, K10024… | 2010 |
| * | K101096 | HT Iii SA Fixture SystemSummary page 1…DZE 3. Predicate Device: The HGII Short Fixture System, Osstem Implant Co., Ltd, K091678 The FuJII SA Fixture System, HIOSSEN Inc., K101096 The HS/HG Prosthetic System, Osstem Implant Co., Ltd, K100245 The NC Temporary Abutment, STRAUMANN USA, K072679… | 2010 |
| * | K100245 | HS/HG Prosthetic SystemSummary page 1…xture System, Osstem Implant Co., Ltd, K091678 The FuJII SA Fixture System, HIOSSEN Inc., K101096 The HS/HG Prosthetic System, Osstem Implant Co., Ltd, K100245 The NC Temporary Abutment, STRAUMANN USA, K072679 The RC Temporary Abutment, STRAUMANN USA, K093027 4. Descri… | 2010 |
| * | K072679 | P.004 AbutmentsSummary page 1…FuJII SA Fixture System, HIOSSEN Inc., K101096 The HS/HG Prosthetic System, Osstem Implant Co., Ltd, K100245 The NC Temporary Abutment, STRAUMANN USA, K072679 The RC Temporary Abutment, STRAUMANN USA, K093027 4. Description: The TS Implant System is a dental implant made o… | 2007 |
| * | K093027 | Straumann RC Temporary AbutmentsSummary page 1…e HS/HG Prosthetic System, Osstem Implant Co., Ltd, K100245 The NC Temporary Abutment, STRAUMANN USA, K072679 The RC Temporary Abutment, STRAUMANN USA, K093027 4. Description: The TS Implant System is a dental implant made of titanium metal intended to be surgically placed in th… | 2010 |
What descends from it? (64)
See all 648 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140507 | Hiossen Prosthetic System | 2014 | 44 |
| K161689 | OSSTEM Implant System - Abutment | 2017 | 38 |
| K160670 | ET US SS Prosthetic system | 2017 | 32 |
| K140934 | Hiossen Implant System | 2014 | 13 |
| K233163 | ZENEX Implant System_Short | 2023 | 1 |
| K232049 | IS-III active Short Implant | 2024 | 0 |
| K200189 | Luna Dental Implant System- Healing Abutment | 2020 | 0 |
| K142557 | Anker Dental Implant System - SB-III, ST and AT series | 2015 | 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 23 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 61 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.
- 1 other device also cites its predicate K091678.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The TS Implant System is indicated for use in partially or fully edentulous
mandibles and maxillae, in support of single or multiple-unit restorations
including: cemented retained, screw retained, or overdenture restorations,
and final or temporary abutment support for fixed bridgework. It is
intended for delayed loading. The abutment is intended for use with a
dental implant fixture to provide support for prosthetic restorations such as
crowns, bridges, or overdenture.
TS Implant System is compatible with abutment in the ET/SS Implant
System
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121585: TS Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121585
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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