510(k) · Cleared
ClearedMdi Ortho
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imtec Corp. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 15, 2004 after a 22-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 20 later devices descend from it.
- Decided
- Sep 15, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 3 citing it directly.
- This deviceK042289 Mdi OrthoImtec Corp. · 2004
- Descendant · cites it directly · 19 of its ownK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- Descendant · 2 generations on · 14 of its ownK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- Descendant · 3 generations on · 13 of its ownK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- Descendant · cites it directly · 5 of its ownK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
- Descendant · 2 generations on · 3 of its ownK161335 Dual Top Screw SystemJeil Medical Corporation · 2017
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K060126Absoanchor MicroimplantDentos, Inc. · 2006 · cites it directly19descendants
- K071490Leone Orthodontic Mini ImplantLeone S.P.A. · 2008 · 2 generations on14descendants
- K090476Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009 · 3 generations on13descendants
- K110392PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011 · cites it directly5descendants
- K161335Dual Top Screw SystemJeil Medical Corporation · 2017 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042289 | Mdi Ortho | Imtec Corp. | 2004 | — |
| +1 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| +2 | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 2008 | — |
| +3 | K090476 | Syntec Orthodontic Mini Screw | Syntec Scientific Corp. | 2009 | — |
| +1 | K110392 | PSM Lomas / Benefit Screws | Psm Medical Solutions | 2011 | — |
| +2 | K161335 | Dual Top Screw System | Jeil Medical Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (20)
See all 203 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, K060126 (Dentos, Inc., 2006) has gone furthest, with 19 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?
Indicated to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Implants are intended for single use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042289 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042289: Mdi Ortho.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042289
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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