510(k) · Cleared
ClearedAnkylos C/X Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl., Inc. · DZE Implant, Endosseous, Root-Form
Cleared on May 22, 2009 as substantially equivalent to K041509 (Friadent GmbH, 2004) and 1 other predicate after a 151-day review. Its family tree reaches back 7 generations to 1990. 290 later devices descend from it.
- Decided
- May 22, 2009
- Review
- 151 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K894595 (1990). 20 ancestors in all. 290 later devices descend from it, 8 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 4 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 2 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 1 generation backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- This deviceK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- Descendant · cites it directly · 199 of its ownK101004 Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini…Astra Tech, Inc. · 2010
- Descendant · 2 generations on · 197 of its ownK120338 Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later…Astra Tech, Inc. · 2012
- Descendant · cites it directly · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · cites it directly · 180 of its ownK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- Descendant · 2 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
Showing 5 of 290 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 290 · See all- K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc. · 2010 · cites it directly199descendants
- K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc. · 2012 · 2 generations on197descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · cites it directly196descendants
- K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · cites it directly180descendants
- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 2 generations on127descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −4 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −2 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −1 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| 0 (this device) | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| +1 | K101004 | Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment… | Astra Tech, Inc. | 2010 | — |
| +2 | K120338 | Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in… | Astra Tech, Inc. | 2012 | — |
| +1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +1 | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| +2 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
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 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 10 | 0 |
| 2015 | 13 | 0 |
| 2016 | 12 | 0 |
| 2017 | 14 | 0 |
| 2018 | 13 | 0 |
| 2019 | 17 | 0 |
| 2020 | 23 | 0 |
| 2021 | 22 | 0 |
| 2022 | 26 | 0 |
| 2023 | 36 | 0 |
| 2024 | 36 | 0 |
| 2025 | 40 | 0 |
| 2026 | 22 | 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 |
|---|---|---|---|
| * | K041509 | Ankylos Dental Implant SystemSummary page 1…Device Number Date Cleared DENTSPLY ANKYLOSO plus Dental Implant K04 1509 08/26/2004 International Inc. System DENTSPLY Friadent Implant Systems… | 2004 |
| * | K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant SystemsSummary page 1…K04 1509 08/26/2004 International Inc. System DENTSPLY Friadent Implant Systems K073075 03/31/2008 International 4. Description of Device: The new ANKYLOS® C/X Dental Implant Syste… | 2008 |
What descends from it? (290)
See all 2908 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101004 | Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis… | 2010 | 199 |
| K120414 | Osseospeed Plus | 2012 | 196 |
| K101945 | Neodent Implant System | 2011 | 180 |
| K140347 | Ankylos C/X Implant System | 2014 | 6 |
| K131066 | Axiom Reg | 2014 | 2 |
| K151757 | IMMEDIATELOAD Dental Implant System | 2016 | 0 |
| K151588 | maxFit II Dental Implant System | 2016 | 0 |
| K141188 | Microdent Genius Implant System | 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 19 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K101004 (Astra Tech, Inc., 2010) has gone furthest, with 199 descendants of its own.
- 9 other devices also cite its predicate K041509.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The ANKYLOS® C/X Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083805: Ankylos C/X 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/K083805
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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