510(k) · Cleared
ClearedImplance Dental Implant System, Implance Dental Abutment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 12, 2016 as substantially equivalent to K073486 (Dentis Co., Ltd., 2008) and 1 other predicate after a 227-day review. Its family tree reaches back 9 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 12, 2016
- Review
- 227 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K944964 (1995). 141 ancestors in all, the oldest K820013 (1982). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations between
- 3 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 2 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 1 generation backK073486 Dentis Dental Implant SystemDentis Co., Ltd. · 2008
- This deviceK160221 Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016
- Descendant · cites it directly · 1 of its ownK181266 Implantswiss Dental Implant System, Implantswiss Dental Abutment…Novodent SA · 2018
- Descendant · 2 generations on · 0 of its ownK200867 Implantswiss Dental Implant System and Implantswiss Dental Abutment…Novodent SA · 2020
- Descendant · cites it directly · 0 of its ownK163640 QZA and RS Dental Implant SystemsTrinon Titanium GmbH · 2017
Show all 9 generations
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 7 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 6 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 5 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 4 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 3 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 2 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 1 generation backK073486 Dentis Dental Implant SystemDentis Co., Ltd. · 2008
- This deviceK160221 Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016
Most influential descendants
Showing 3 of 3 · See all- K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA · 2018 · cites it directly1descendant
- K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA · 2020 · 2 generations on0descendants
- K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −8 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −5 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −4 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −3 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| −2 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| −1 | K073486 | Dentis Dental Implant System | Dentis Co., Ltd. | 2008 | — |
| 0 (this device) | K160221 | Implance Dental Implant System, Implance Dental Abutment System | Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. | 2016 | — |
| +1 | K181266 | Implantswiss Dental Implant System, Implantswiss Dental Abutment System | Novodent SA | 2018 | — |
| +2 | K200867 | Implantswiss Dental Implant System and Implantswiss Dental Abutment System | Novodent SA | 2020 | — |
| +1 | K163640 | QZA and RS Dental Implant Systems | Trinon Titanium GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 13 | 0 |
| 1994 | 11 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 15 | 0 |
| 2003 | 9 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K073486 | Dentis Dental Implant SystemSummary page 4…II Product Codes DZE (Primary Product Code), NHA III. PREDICATE DEVICE Primary Predicate Device: Dentis Dental Device - K073486 Predicate Device: Klockner Dental implant abutment - K122988… | 2008 |
| * | K122988 | Klockner Dental Implant AbutmentsSummary page 4…HA III. PREDICATE DEVICE Primary Predicate Device: Dentis Dental Device - K073486 Predicate Device: Klockner Dental implant abutment - K122988 Page 1-8 IV DEVICE DESCRIPTION The I… | 2013 |
What descends from it? (3)
2 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 1.3 years on median.
- 14 of the 141 ancestors have a recall of any class.
- Of its descendants, K181266 (Novodent SA, 2018) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K073486.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Implance Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units’ prosthetic appliance attachment to restore a patient’s chewing function. Implance Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate…
Read the full statement (138 words)
Implance Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units’ prosthetic appliance attachment to restore a patient’s chewing function.
Implance Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading.
Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.
Implance Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160221: Implance Dental Implant System, Implance Dental Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160221
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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