510(k) · Cleared
ClearedAnkylos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Ceramco · DZE Implant, Endosseous, Root-Form
Cleared on Aug 22, 2003 as substantially equivalent to K984104 (Straumann USA, 1999) and 1 other predicate after a 738-day review. Its family tree reaches back 3 generations to 1990. 7 later devices descend from it.
- Decided
- Aug 22, 2003
- Review
- 738 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K894595 (1990). 10 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 2 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 1 generation backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- This deviceK012681 AnkylosDentsply Ceramco · 2003
- Descendant · cites it directly · 3 of its ownK040946 Ankylos Dental Implant SystemFriadent GmbH · 2004
- Descendant · 2 generations on · 2 of its ownK040757 Sic ProSic Invent AG · 2005
- Descendant · cites it directly · 1 of its ownK081226 Simpact Implant SystemSimpact, LLC · 2008
- Descendant · 3 generations on · 1 of its ownK061500 Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG · 2006
- Descendant · 2 generations on · 0 of its ownK083141 Simpact Endosseous Dental Implant SystemSimpact, LLC · 2008
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040946Ankylos Dental Implant SystemFriadent GmbH · 2004 · cites it directly3descendants
- K040757Sic ProSic Invent AG · 2005 · 2 generations on2descendants
- K081226Simpact Implant SystemSimpact, LLC · 2008 · cites it directly1descendant
- K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG · 2006 · 3 generations on1descendant
- K083141Simpact Endosseous Dental Implant SystemSimpact, LLC · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −2 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −1 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| 0 (this device) | K012681 | Ankylos | Dentsply Ceramco | 2003 | — |
| +1 | K040946 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| +2 | K040757 | Sic Pro | Sic Invent AG | 2005 | — |
| +1 | K081226 | Simpact Implant System | Simpact, LLC | 2008 | — |
| +3 | K061500 | Sicace Dental Implant System and Sic Angled Abutments | Sic Invent AG | 2006 | — |
| +2 | K083141 | Simpact Endosseous Dental Implant System | Simpact, LLC | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 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 |
|---|---|---|---|
| * | K984104 | Iti Dental Implant SystemSummary page 1…86 0wne.r.- .Op_erator: 2246968 Classification; Class Ill Predicate Devices Straumann IT1 Implant (5lOk - 984104) Brenemerk System (510k - 992937) Description of Device Ankylos dental implants consist of uncoated pure titanium (grade 2 per… | 1999 |
| * | K992937 | Dental ImplantSummary page 1…2246968 Classification; Class Ill Predicate Devices Straumann IT1 Implant (5lOk - 984104) Brenemerk System (510k - 992937) Description of Device Ankylos dental implants consist of uncoated pure titanium (grade 2 per IS0 5832Al). The threaded area fe… | 2000 |
What descends from it? (7)
3 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 13 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K040946 (Friadent GmbH, 2004) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K984104.
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 or 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. Patient must be subject for dental treatment with endosseous implants
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012681: Ankylos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012681
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026