510(k) · Cleared
ClearedLeone Orthodontic Implant TAD (Temporary Anchorage Device)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leone S.P.A. · OAT Implant, Endosseous, Orthodontic
Cleared on Jun 19, 2025 as substantially equivalent to K110392 (Psm Medical Solutions, 2011) after a 267-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Jun 19, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K894844 (1990). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 6 generations between
- 3 generations backK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- 2 generations backK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- 1 generation backK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
- This deviceK242944 Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A. · 2025
Show all 10 generations
- Root · 10 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 9 generations backK973353 Bonding BaseStraumann USA · 1997
- 8 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 7 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 6 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 5 generations backK042965 Tomas PinDentaurum, Inc. · 2005
- 4 generations backK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- 3 generations backK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- 2 generations backK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- 1 generation backK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
- This deviceK242944 Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −9 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −8 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −7 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −6 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −5 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| −4 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| −3 | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 2008 | — |
| −2 | K090476 | Syntec Orthodontic Mini Screw | Syntec Scientific Corp. | 2009 | — |
| −1 | K110392 | PSM Lomas / Benefit Screws | Psm Medical Solutions | 2011 | — |
| 0 (this device) | K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 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 OAT? 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 OAT device
- #1 K260268 OrthoEasy Pal; OrthoEasy Pal Long Neckscore 13.2 · 7 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 |
|---|---|---|---|
| * | K110392 | PSM Lomas / Benefit ScrewsSummary page 5…dosseous dental implant Regulation number: 872.3640 Classification Name: Implant, Endosseous, Orthodontic Product Code : OAT PREDICATE DEVICE Trade or Proprietary Name: K110392, PSM LOMAS/BENEFIT Screws Regulation Description: Endosseous dental implant Regulation number: 872.3640 Classification Name: Impl… | 2011 |
| † | K070483 | Leone Monoimplant for O-Ring Overdenture | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- None of the 25 ancestors has a recall.
- 1 other device also cites its predicate K110392.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OAT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAT
224in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAT
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAT
5in 2025
MAUDE reports naming product code OAT, 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 | 6 | 104 | 2 | 2 |
| 2008 | 3 | 94 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 152 | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 28 |
| 2016 | 2 | — | 0 | 12 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 289 | 0 | 38 |
| 2021 | 4 | 224 | 0 | 68 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 1 | — | 0 | 78 |
| 2024 | 2 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Leone Orthodontic Implant TADs (Temporary Anchorage Devices) are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242944 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242944: Leone Orthodontic Implant TAD (Temporary Anchorage Device).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242944
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