510(k) · Cleared
ClearedAnker Dental Implant System - SB-III, ST and AT series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Global Technology Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 21, 2015 as substantially equivalent to K131165 (Alliance Global, 2013) and 5 other predicates after a 375-day review. Its family tree reaches back 13 generations to 1990.
- Decided
- Sep 21, 2015
- Review
- 375 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K894844 (1990). 202 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 9 generations between
- 3 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 2 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 1 generation backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- This deviceK142557 Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd. · 2015
Show all 13 generations
- Root · 13 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 12 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 11 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 10 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 9 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 8 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 7 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 6 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 5 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 4 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 3 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 2 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 1 generation backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- This deviceK142557 Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −12 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −11 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −10 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −9 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −8 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −7 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −6 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −5 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −4 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −3 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −2 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −1 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 8 | 0 |
| 2001 | 10 | 0 |
| 2002 | 14 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 9 | 0 |
| 2006 | 17 | 0 |
| 2007 | 13 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K131165 | Anker Dental Implant SystemSummary page 4…orm endosseous dental implant 5. Device Classification: Class II 6. Regulation Number: 21 CFR 872.3640 Panel: Dental Product Code: DZE 7. Predicate Devices: K131165 Anker Dental Implant System (Primary Predicate for proposed fixtures SB-III, ST, and proposed abutments SB-II… | 2013 |
| * | K123784 | Straumann Dental Implant SystemSummary page 4…Predicate Devices: K131165 Anker Dental Implant System (Primary Predicate for proposed fixtures SB-III, ST, and proposed abutments SB-III) K123784 Straumann Dental Implant System SLA & SLActive & Roxolid Product Families (Reference Predicate for pro… | 2013 |
| * | K121585 | TS Implant SystemSummary page 4…oposed abutments of ST and AT) K120822 Straumann CARES Variobase Abutments (Reference Predicate for proposed abutments of ST and AT) K121585 Osstem TS Implant System (Reference Predicate for proposed abutment SB-III) K052957 Dentiu… | 2013 |
| * | K052957 | Implantium ProstheticsSummary page 4…for proposed abutments of ST and AT) K121585 Osstem TS Implant System (Reference Predicate for proposed abutment SB-III) K052957 Dentium Implantium Prosthetics (Reference Predicate for proposed abutment SB-III) 510(k) Anker Denta… | 2006 |
| * | K130808 | Straumann Healing Abutments, Healing Caps, Closure ScrewsSummary page 4…Straumann Dental Implant System SLA & SLActive & Roxolid Product Families (Reference Predicate for proposed fixture AT, ST) K130808 Straumann healing abutments, healing caps, closure screws (Reference Predicate for proposed abutments… | 2013 |
| * | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Summary page 4…ST) K130808 Straumann healing abutments, healing caps, closure screws (Reference Predicate for proposed abutments of ST and AT) K120822 Straumann CARES Variobase Abutments (Reference Predicate for proposed abutments of ST and AT) K12… | 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 25 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 21 of the 202 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. Anker Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are…
Read the full statement (137 words)
Anker Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function.
Anker Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).
Specific indications for small diameter (͟3.3mm) and short (length < 7mm) dental implants:
Because of their reduced mechanical stability, small diameter and short implants are only used in cases with a low mechanical load. We recommend only used in the mandibular anterior region and maxillary lateral incisor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142557: Anker Dental Implant System - SB-III, ST and AT series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142557
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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