510(k) · Cleared
ClearedLeone Orthodontic Mini Implant
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 Feb 22, 2008 as substantially equivalent to K060126 (Dentos, Inc., 2006) after a 268-day review. Its family tree reaches back 7 generations to 1990. 14 later devices descend from it.
- Decided
- Feb 22, 2008
- Review
- 268 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894844 (1990). 19 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 6 generations backK973353 Bonding BaseStraumann USA · 1997
- 5 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 4 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 3 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 2 generations backK042965 Tomas PinDentaurum, Inc. · 2005
- 1 generation backK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- This deviceK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- Descendant · cites it directly · 13 of its ownK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- Descendant · 2 generations on · 5 of its ownK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
- Descendant · 3 generations on · 3 of its ownK161335 Dual Top Screw SystemJeil Medical Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK152297 OBS Anchorage ScrewBomei Co, Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK142001 Syntec Wetali Orthodontic Mini ScrewsSyntec Scientific Corporation - Taipei Office · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K090476Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009 · cites it directly13descendants
- K110392PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011 · 2 generations on5descendants
- K161335Dual Top Screw SystemJeil Medical Corporation · 2017 · 3 generations on3descendants
- K152297OBS Anchorage ScrewBomei Co, Ltd. · 2016 · 2 generations on1descendant
- K142001Syntec Wetali Orthodontic Mini ScrewsSyntec Scientific Corporation - Taipei Office · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −6 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −5 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −4 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −3 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −2 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| −1 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| 0 (this device) | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 2008 | — |
| +1 | K090476 | Syntec Orthodontic Mini Screw | Syntec Scientific Corp. | 2009 | — |
| +2 | K110392 | PSM Lomas / Benefit Screws | Psm Medical Solutions | 2011 | — |
| +3 | K161335 | Dual Top Screw System | Jeil Medical Corporation | 2017 | — |
| +2 | K152297 | OBS Anchorage Screw | Bomei Co, Ltd. | 2016 | — |
| +2 | K142001 | Syntec Wetali Orthodontic Mini Screws | Syntec Scientific Corporation - Taipei Office | 2015 | — |
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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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 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 |
|---|---|---|---|
| * | K060126 | Absoanchor MicroimplantSummary page 1…s Dental Implant The legally marketed device to which we are claiming equivalence [21 CFR 807.92(a)(3)]: Dentos Inc, Dentos AbsoAnchor orthodontic microimplant (K060126) Description of the device: The Leone orthodontic mini implant is a medical device made of stainless steel for… | 2006 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090476 | Syntec Orthodontic Mini Screw | 2009 | 13 |
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 18 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K090476 (Syntec Scientific Corp., 2009) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K060126.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 mini implant is an implant device providing a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily in the maxillary and mandibular bone and must be removed after orthodontic treatment has been completed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071490 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071490: Leone Orthodontic Mini Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071490
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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