510(k) · Cleared
ClearedLin/Liou Orthodontic Mini Anchor System (Lomas)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mondeal Medical Systems GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Jan 13, 2005 after a 136-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Jan 13, 2005
- Review
- 136 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK042345 Lin/Liou Orthodontic Mini Anchor System (Lomas)Mondeal Medical Systems GmbH · 2005
- 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
- Descendant · 2 generations on · 0 of its ownK242944 Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A. · 2025
- Descendant · 3 generations on · 0 of its ownK231913 T-FITTechwin Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK210559 ATOZ Mini-ScrewMk Meditech, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K110392PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011 · cites it directly5descendants
- K161335Dual Top Screw SystemJeil Medical Corporation · 2017 · 2 generations on3descendants
- K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A. · 2025 · 2 generations on0descendants
- K231913T-FITTechwin Co., Ltd. · 2024 · 3 generations on0descendants
- K210559ATOZ Mini-ScrewMk Meditech, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042345 | Lin/Liou Orthodontic Mini Anchor System (Lomas) | Mondeal Medical Systems GmbH | 2005 | — |
| +1 | K110392 | PSM Lomas / Benefit Screws | Psm Medical Solutions | 2011 | — |
| +2 | K161335 | Dual Top Screw System | Jeil Medical Corporation | 2017 | — |
| +2 | K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. | 2025 | — |
| +3 | K231913 | T-FIT | Techwin Co., Ltd. | 2024 | — |
| +3 | K210559 | ATOZ Mini-Screw | Mk Meditech, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (7)
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?
- Of its descendants, K110392 (Psm Medical Solutions, 2011) has gone furthest, with 5 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 Lin/Liou Orthodontic Mini Anchor System (LOMAS) is intended to provide 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 has been completed. Screws are intended for single use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042345 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042345: Lin/Liou Orthodontic Mini Anchor System (Lomas).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042345
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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