510(k) · Cleared
ClearedTSIII BA Fixture
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 Apr 21, 2017 as substantially equivalent to K151626 (Hiossen, Inc., 2016) and 1 other predicate after a 168-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Apr 21, 2017
- Review
- 168 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K894595 (1990). 153 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- 2 generations backK140934 Hiossen Implant SystemHiossen, Inc. · 2014
- 1 generation backK151626 ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · Recalled
- This deviceK163088 TSIII BA FixtureOsstem Implant Co., Ltd. · 2017
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 11 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 10 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 9 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 8 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 7 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 6 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 4 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 3 generations backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- 2 generations backK140934 Hiossen Implant SystemHiossen, Inc. · 2014
- 1 generation backK151626 ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · Recalled
- This deviceK163088 TSIII BA FixtureOsstem Implant Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −11 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −10 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −9 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −8 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −7 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −6 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −4 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −3 | K103537 | ET Iii SA Ultra Wide System | Hiossen, Inc. | 2011 | — |
| −2 | K140934 | Hiossen Implant System | Hiossen, Inc. | 2014 | — |
| −1 | K151626 | ET III Bio-SA Fixture System | Hiossen, Inc. | 2016 | 1 |
| 0 (this device) | K163088 | TSIII BA Fixture | Osstem Implant Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 10 | 0 |
| 2003 | 9 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 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? (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 |
|---|---|---|---|
| * | K151626 | ET III Bio-SA Fixture SystemSummary page 4…e : Endosseous Dental Implant Regulation Number : 21CFR872.3640 Device Classification: ClassⅡ Product Code: DZE 3. Predicate Device: Primary Predicate K151626, ETIII Bio-A Fixture System, HIOSSEN Inc. Reference predicate K121995, TS Fixture System, OSSTEM Implant Co., Ltd. 4. Devic… | 2016 |
| * | K121995 | TS Fixture SystemSummary page 4…ice Classification: ClassⅡ Product Code: DZE 3. Predicate Device: Primary Predicate K151626, ETIII Bio-A Fixture System, HIOSSEN Inc. Reference predicate K121995, TS Fixture System, OSSTEM Implant Co., Ltd. 4. Device Description: (1) Design Features (Same with ETIII Bio-SA Fixture Syst… | 2012 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 12 of the 153 ancestors have a recall of any class.
- 1 other device also cites its predicate K151626.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
TSIII BA Fixture is indicated for use in partially or fully edentulous mandibles and maxillae,
in support of single or multiple-units restorations including; cemented retained, screw retained,
or overdenture restorations, and final or temporary abutment support for fixed bridgework. It
is intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163088: TSIII BA Fixture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163088
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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