510(k) · Cleared
ClearedAnker Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Global · DZE Implant, Endosseous, Root-Form
Cleared on Nov 14, 2013 as substantially equivalent to K041368 (Dentium Co., Ltd., 2004) and 1 other predicate after a 204-day review. Its family tree reaches back 10 generations to 1990. 1 later device descends from it.
- Decided
- Nov 14, 2013
- Review
- 204 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K894595 (1990). 30 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK091208 GS Iii SystemOsstem Implant Co., Ltd. · 2010
- This deviceK131165 Anker Dental Implant SystemAlliance Global · 2013
- Descendant · cites it directly · 0 of its ownK142557 Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd. · 2015
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 backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK091208 GS Iii SystemOsstem Implant Co., Ltd. · 2010
- This deviceK131165 Anker Dental Implant SystemAlliance Global · 2013
Most influential descendants
Showing 1 of 1 · See all- K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd. · 2015 · cites it directly0descendants
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 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −2 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −1 | K091208 | GS Iii System | Osstem Implant Co., Ltd. | 2010 | — |
| 0 (this device) | K131165 | Anker Dental Implant System | Alliance Global | 2013 | — |
| +1 | K142557 | Anker Dental Implant System - SB-III, ST and AT series | Alliance Global Technology Co., Ltd. | 2015 | — |
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 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 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 |
|---|---|---|---|
| * | K041368 | Dentium CO., LTD. ImplantiumSummary page 1…0 Panel: Dental Product Code: DZE Predicate Device: (1)Predicate Device Name: Dentium Co.. Ltd Implanrium Manufacturer: Dentium Company Limited 5 10O(k) Number: K041368 (2)Predicate Device Name: Osstem GS-I1I system Manufacturer: OSSTEM Implant Co., Ltd. 5 10(k) Number: K(091208 510(k) K… | 2004 |
| * | K091208 | GS Iii SystemSummary page 3…872.3640 3. 4. 510K No. Design 3 K131165 K091208 K041368 5. Intended Use Anker Dental Implant The GS Ill System is… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 1.4 years on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K142557 (Alliance Global Technology Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K041368.
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?
Anker Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It is intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131165: Anker Dental 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/K131165
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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