510(k) · Cleared
ClearedOrtho Organizers Temporary Orthodontic Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Organizers, Inc. · OAT Implant, Endosseous, Orthodontic
Cleared on Jul 31, 2006 after an 87-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Jul 31, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK061266 Ortho Organizers Temporary Orthodontic AnchorOrtho Organizers, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK063149 Orthodontic Taads (Temporary Anatomical Anchor Device System)T.O.a.D.S., LLC · 2007
- Descendant · 2 generations on · 0 of its ownK122069 Storm Mini ScrewLancer Orthodontics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK081393 Orthodontic Temporary Anchorage Implant ScrewG & H Wire Co. · 2008
Most influential descendants
Showing 3 of 3 · See all- K063149Orthodontic Taads (Temporary Anatomical Anchor Device System)T.O.a.D.S., LLC · 2007 · cites it directly2descendants
- K122069Storm Mini ScrewLancer Orthodontics, Inc. · 2013 · 2 generations on0descendants
- K081393Orthodontic Temporary Anchorage Implant ScrewG & H Wire Co. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061266 | Ortho Organizers Temporary Orthodontic Anchor | Ortho Organizers, Inc. | 2006 | — |
| +1 | K063149 | Orthodontic Taads (Temporary Anatomical Anchor Device System) | T.O.a.D.S., LLC | 2007 | — |
| +2 | K122069 | Storm Mini Screw | Lancer Orthodontics, Inc. | 2013 | — |
| +1 | K081393 | Orthodontic Temporary Anchorage Implant Screw | G & H Wire Co. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 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?
The FDA summary names no predicate by number.
What descends from it? (3)
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, K063149 (T.O.a.D.S., LLC, 2007) has gone furthest, with 2 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.
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 Ortho Organizers Temporary Orthodontic Anchor is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061266 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061266: Ortho Organizers Temporary Orthodontic Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061266
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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