510(k) · Cleared
ClearedAnkylos Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Friadent GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Aug 26, 2004 as substantially equivalent to K032158 (Friadent GmbH, 2003) and 1 other predicate after an 80-day review. Its family tree reaches back 6 generations to 1990. 325 later devices descend from it.
- Decided
- Aug 26, 2004
- Review
- 80 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K894595 (1990). 16 ancestors in all. 325 later devices descend from it, 10 citing it directly.
- Root · 6 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 4 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 3 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 2 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 1 generation backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- This deviceK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- Descendant · cites it directly · 290 of its ownK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- Descendant · 2 generations on · 199 of its ownK101004 Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini…Astra Tech, Inc. · 2010
- Descendant · 3 generations on · 197 of its ownK120338 Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later…Astra Tech, Inc. · 2012
- Descendant · 2 generations on · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · 2 generations on · 180 of its ownK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
Showing 5 of 325 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 325 · See all- K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009 · cites it directly290descendants
- K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc. · 2010 · 2 generations on199descendants
- K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc. · 2012 · 3 generations on197descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · 2 generations on196descendants
- K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · 2 generations on180descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −5 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −4 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −3 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −2 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −1 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| 0 (this device) | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| +1 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| +2 | K101004 | Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment… | Astra Tech, Inc. | 2010 | — |
| +3 | K120338 | Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in… | Astra Tech, Inc. | 2012 | — |
| +2 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +2 | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 14 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 15 | 0 |
| 2018 | 14 | 0 |
| 2019 | 21 | 0 |
| 2020 | 24 | 0 |
| 2021 | 22 | 0 |
| 2022 | 29 | 0 |
| 2023 | 36 | 0 |
| 2024 | 38 | 0 |
| 2025 | 40 | 0 |
| 2026 | 24 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K012087 | FDA’s K012087 is Cordis Palmaz Genesis Transhepatic Biliary Stent Our reading of the summary gave K012087, FDA’s number for Cordis Palmaz Genesis Transhepatic Biliary Stent (Cordis Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ANKYLOS® Dental Implant System”. Kept off the family tree. Summary page 1…CATE DEVICES Company Device 510(k) No. Date Cleared FRIADENT GmbH ANKYLOS® K012087 08/22/2003 Dental Implant System FRIADENT GtnbH XiVE®… | 2001 |
| * | K032158 | Xive Dental Implant System MultipleSummary page 1…S® K012087 08/22/2003 Dental Implant System FRIADENT GtnbH XiVE® K032 158 08/14/2003 Dental Implant System FRtADENT GmbH] YiVE®… | 2003 |
| * | K021318 | Xive Dental Implant SystemSummary page 1…K032 158 08/14/2003 Dental Implant System FRtADENT GmbH] YiVE® K021318 07/02/2002 Dental lImplant System FRIADENT GmbHl ANKYLOS ® Dental Implan… | 2002 |
What descends from it? (325)
See all 32510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083805 | Ankylos C/X Dental Implant System | 2009 | 290 |
| K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems | 2006 | 66 |
| K130999 | Osseospeed Profile EV | 2013 | 18 |
| K142167 | Medentika Abutment System | 2015 | 7 |
| K131644 | Ankylos Syncone Abutment 5(Degree) | 2014 | 1 |
| K081226 | Simpact Implant System | 2008 | 1 |
| K141188 | Microdent Genius Implant System | 2015 | 0 |
| K072730 | Friadent Cercon and Ankylos Cercon Balance Abutments | 2008 | 0 |
| K073067 | Ankylos Dental Implant System/Claims | 2008 | 0 |
| K073073 | Ankylos Temporary Abutment Balance | 2008 | 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 14 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K083805 (Dentsply Intl., Inc., 2009) has gone furthest, with 290 descendants of its own.
- 5 other devices also cite its predicate K032158.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 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 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041509 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041509: Ankylos Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041509
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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