510(k) · Cleared
ClearedOrthodontic Temporary Anchorage Implant Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G & H Wire Co. · OAT Implant, Endosseous, Orthodontic
Cleared on Aug 21, 2008 as substantially equivalent to K061266 (Ortho Organizers, Inc., 2006) and 2 other predicates after a 94-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Aug 21, 2008
- Review
- 94 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K894844 (1990). 22 ancestors in all. No later device cites it as a predicate yet.
- 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 backK063149 Orthodontic Taads (Temporary Anatomical Anchor Device System)T.O.a.D.S., LLC · 2007
- This deviceK081393 Orthodontic Temporary Anchorage Implant ScrewG & H Wire Co. · 2008
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 | K063149 | Orthodontic Taads (Temporary Anatomical Anchor Device System) | T.O.a.D.S., LLC | 2007 | — |
| 0 (this device) | K081393 | Orthodontic Temporary Anchorage Implant Screw | G & H Wire Co. | 2008 | — |
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 |
| 2005 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K061266 | Ortho Organizers Temporary Orthodontic AnchorSummary page 1…Predicate Device(s) Ancor Pro Temporary Ortho Organizers Orthodontic Anchorage K061266 System Dentaurum Tomas Temporary Micro K042965… | 2006 |
| * | K042965 | Tomas PinSummary page 1…Orthodontic Anchorage K061266 System Dentaurum Tomas Temporary Micro K042965 Anchorage T.O.A.D.S. Temporary Anatomical K063149… | 2005 |
| * | K063149 | Orthodontic Taads (Temporary Anatomical Anchor Device System)Summary page 1…Tomas Temporary Micro K042965 Anchorage T.O.A.D.S. Temporary Anatomical K063149 Anchor Device… | 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 18 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- None of the 22 ancestors has a recall.
- 1 other device also cites its predicate K061266.
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?
Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The screw is used temporarily and is removed after orthodontic treatment has been completed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081393 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081393: Orthodontic Temporary Anchorage Implant Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081393
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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