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 Jul 1, 2004 as substantially equivalent to K012681 (Dentsply Ceramco, 2003) after an 80-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.
- Decided
- Jul 1, 2004
- Review
- 80 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894595 (1990). 11 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 3 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 2 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 1 generation backK012681 AnkylosDentsply Ceramco · 2003
- This deviceK040946 Ankylos Dental Implant SystemFriadent GmbH · 2004
- Descendant · cites it directly · 2 of its ownK040757 Sic ProSic Invent AG · 2005
- Descendant · 2 generations on · 1 of its ownK061500 Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG · 2006
- Descendant · 2 generations on · 0 of its ownK073622 Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −3 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −2 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −1 | K012681 | Ankylos | Dentsply Ceramco | 2003 | — |
| 0 (this device) | K040946 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| +1 | K040757 | Sic Pro | Sic Invent AG | 2005 | — |
| +2 | K061500 | Sicace Dental Implant System and Sic Angled Abutments | Sic Invent AG | 2006 | — |
| +2 | K073622 | Easy Grip Dental Implant System | T.F.I. System S.R.L | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K012681 | AnkylosSummary page 1…OF PREDICATE DEVICES Company Device 510(k) No. Date Cleared Dentsply Ceramco ANKYLOS" Dental Implant K012681 08/22/2003 System 15.4 DEVICE DESCRIPTION The ANKYLOS dental implant… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040757 | Sic Pro | 2005 | 2 |
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 5 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K040757 (Sic Invent AG, 2005) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K012681.
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 healling 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 interforminal 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/K040946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040946: Ankylos 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/K040946
Report an extraction error
Are you the manufacturer?
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