510(k) · Cleared
ClearedAarhus Anchorage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicon EG · DZE Implant, Endosseous, Root-Form
Cleared on Aug 19, 2004 after a 72-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Aug 19, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK041527 Aarhus Anchorage SystemMedicon EG · 2004
- Descendant · cites it directly · 4 of its ownK052471 HDC Spider ScrewHdc S.R.L. · 2005
- Descendant · 2 generations on · 2 of its ownK071851 HDC Sterile Spider ScrewHdc S.R.L. · 2007
- Descendant · cites it directly · 0 of its ownK130476 Orthodontic Miniscrew for Absolute AnchorageDental Morelli · 2014
- Descendant · 3 generations on · 0 of its ownK122069 Storm Mini ScrewLancer Orthodontics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK102769 Neodent Implant for Orthodontic AnchorageJjgc Industria E Comercio DE Materiais Dentarios S · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K052471HDC Spider ScrewHdc S.R.L. · 2005 · cites it directly4descendants
- K071851HDC Sterile Spider ScrewHdc S.R.L. · 2007 · 2 generations on2descendants
- K130476Orthodontic Miniscrew for Absolute AnchorageDental Morelli · 2014 · cites it directly0descendants
- K122069Storm Mini ScrewLancer Orthodontics, Inc. · 2013 · 3 generations on0descendants
- K102769Neodent Implant for Orthodontic AnchorageJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041527 | Aarhus Anchorage System | Medicon EG | 2004 | — |
| +1 | K052471 | HDC Spider Screw | Hdc S.R.L. | 2005 | — |
| +2 | K071851 | HDC Sterile Spider Screw | Hdc S.R.L. | 2007 | — |
| +1 | K130476 | Orthodontic Miniscrew for Absolute Anchorage | Dental Morelli | 2014 | — |
| +3 | K122069 | Storm Mini Screw | Lancer Orthodontics, Inc. | 2013 | — |
| +1 | K102769 | Neodent Implant for Orthodontic Anchorage | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | — | Medicon eG, Micro Titanium Plate System Named without a submission number | |
| * | — | KLS Martin L.P., Ortho Anchorage System Named without a submission number |
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?
- Of its descendants, K052471 (Hdc S.R.L., 2005) has gone furthest, with 4 descendants of its own.
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?
The Aarhus Anchorage System is a threaded titanium dental implant screw intended to
serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the
orthodontic movement of teeth. The device is used temporarily and is removed after
orthodontic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041527: Aarhus Anchorage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041527
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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