510(k) · Cleared
ClearedAnkylos C/X 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 Aug 20, 2014 as substantially equivalent to K083805 (Dentsply Intl., Inc., 2009) and 1 other predicate after a 190-day review. Its family tree reaches back 8 generations to 1990. 6 later devices descend from it.
- Decided
- Aug 20, 2014
- Review
- 190 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K894595 (1990). 22 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 5 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 2 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 1 generation backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- This deviceK140347 Ankylos C/X Implant SystemDentsply Intl., Inc. · 2014
- Descendant · cites it directly · 4 of its ownK172505 MIS C1 Narrow Platform Conical Connection Implant System, MIS C1…Mis Implants Technologies, Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK241692 MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK251647 MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant…Dentsply Sirona, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK251297 MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK183079 Conometric AbutmentsDentsply Sirona, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd. · 2017 · cites it directly4descendants
- K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc. · 2024 · 2 generations on2descendants
- K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc. · 2025 · 3 generations on0descendants
- K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc. · 2025 · 3 generations on0descendants
- K183079Conometric AbutmentsDentsply Sirona, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −5 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −2 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| −1 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| 0 (this device) | K140347 | Ankylos C/X Implant System | Dentsply Intl., Inc. | 2014 | — |
| +1 | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform… | Mis Implants Technologies, Ltd. | 2017 | — |
| +2 | K241692 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2024 | — |
| +3 | K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS… | Dentsply Sirona, Inc. | 2025 | — |
| +3 | K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2025 | — |
| +1 | K183079 | Conometric Abutments | Dentsply Sirona, Inc. | 2019 | — |
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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K083805 | Ankylos C/X Dental Implant SystemSummary page 4…II x Product Code: DZE 3. Predicate Device: ® x ANKYLOS C/X Dental Implant System cleared in K083805 x Bicon Implant 4.0 x 5.0 mm cleared in K092035 (Bicon Implants with a 2.5 mm Internal Connection) 4… | 2009 |
| * | K092035 | Bicon Implants with a 2.5MM Internal ConnectionSummary page 4…3. Predicate Device: ® x ANKYLOS C/X Dental Implant System cleared in K083805 x Bicon Implant 4.0 x 5.0 mm cleared in K092035 (Bicon Implants with a 2.5 mm Internal Connection) 4. Description of Device: The ANKYLOS® C/X Implant 6.… | 2009 |
What descends from it? (6)
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 24 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K172505 (Mis Implants Technologies, Ltd., 2017) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K083805.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
ANKYLOS® C/X lmplants of 8 mm in length or longer are for single-stage or two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X lmplants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.…
Read the full statement (124 words)
ANKYLOS® C/X lmplants of 8 mm in length or longer are for single-stage or two-stage
surgical procedures and cemented, removable or screw retained restorations. The
ANKYLOS® C/X lmplants may be used for immediate placement and function on single
tooth and/or multiple tooth applications when adequate primary stability is achievable, with
appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications
may be splinted.
ANKYLOS® C/X lmplants of 6.6 mm in length are for two-stage surgical procedures and
cemented, removable or screw retained restorations. The ANKYLOS® C/X lmplants may be
used for immediate placement on single tooth and/or multiple tooth applications when
adequate primary stability is achievable, with appropriate occlusal loading, in order to restore
chewing function. Multiple tooth applications may be splinted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140347: Ankylos C/X 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/K140347
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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