510(k) · Cleared
ClearedSyntec Orthodontic Mini Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntec Scientific Corp. · OAT Implant, Endosseous, Orthodontic
Cleared on Jun 18, 2009 as substantially equivalent to K071490 (Leone S.P.A., 2008) after a 114-day review. Its family tree reaches back 8 generations to 1990. 13 later devices descend from it.
- Decided
- Jun 18, 2009
- Review
- 114 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K894844 (1990). 20 ancestors in all. 13 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 7 generations backK973353 Bonding BaseStraumann USA · 1997
- 6 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 5 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 4 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 3 generations backK042965 Tomas PinDentaurum, Inc. · 2005
- 2 generations backK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- 1 generation backK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- This deviceK090476 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
- Descendant · cites it directly · 1 of its ownK152297 OBS Anchorage ScrewBomei Co, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK142001 Syntec Wetali Orthodontic Mini ScrewsSyntec Scientific Corporation - Taipei Office · 2015
- Descendant · 2 generations on · 0 of its ownK242944 Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A. · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K110392PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011 · cites it directly5descendants
- K161335Dual Top Screw SystemJeil Medical Corporation · 2017 · 2 generations on3descendants
- K152297OBS Anchorage ScrewBomei Co, Ltd. · 2016 · cites it directly1descendant
- K142001Syntec Wetali Orthodontic Mini ScrewsSyntec Scientific Corporation - Taipei Office · 2015 · cites it directly1descendant
- K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −7 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −6 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −5 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −4 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −3 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| −2 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| −1 | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 2008 | — |
| 0 (this device) | 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 | — |
| +1 | K152297 | OBS Anchorage Screw | Bomei Co, Ltd. | 2016 | — |
| +1 | K142001 | Syntec Wetali Orthodontic Mini Screws | Syntec Scientific Corporation - Taipei Office | 2015 | — |
| +2 | 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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K071490 | Leone Orthodontic Mini ImplantSummary page 2…dontic mini screws have same intended use as the Leone Orthodontic Mini Implant from Leone SpA, 50 Via P. a Quaracchi Sesto, Fiorentino, IT-500 19, cleared 510 (k) no. K071490, and have equivalent performance characteristics. Device Name Syntec orthodontic mini screws Leone ortho… | 2008 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110392 | PSM Lomas / Benefit Screws | 2011 | 5 |
| K152297 | OBS Anchorage Screw | 2016 | 1 |
| K142001 | Syntec Wetali Orthodontic Mini Screws | 2015 | 1 |
| K202790 | Syntec Orthodontic Mini Screw Extended System | 2021 | 0 |
| K182929 | BIO-RAY A-1 Anchor Screw System | 2019 | 0 |
| K102769 | Neodent Implant for Orthodontic Anchorage | 2011 | 0 |
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 19 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K110392 (Psm Medical Solutions, 2011) has gone furthest, with 5 descendants of its own.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090476: Syntec Orthodontic Mini Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090476
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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