510(k) · Cleared
ClearedOrthodontic Taads (Temporary Anatomical Anchor Device System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
T.O.a.D.S., LLC · OAT Implant, Endosseous, Orthodontic
Cleared on Mar 8, 2007 as substantially equivalent to K060126 (Dentos, Inc., 2006) and 3 other predicates after a 143-day review. Its family tree reaches back 7 generations to 1990. 2 later devices descend from it.
- Decided
- Mar 8, 2007
- Review
- 143 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K894844 (1990). 21 ancestors in all. 2 later devices descend from it, 2 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 deviceK063149 Orthodontic Taads (Temporary Anatomical Anchor Device System)T.O.a.D.S., LLC · 2007
- Descendant · cites it directly · 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 2 of 2 · See allView 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) | K063149 | Orthodontic Taads (Temporary Anatomical Anchor Device System) | T.O.a.D.S., LLC | 2007 | — |
| +1 | K122069 | Storm Mini Screw | Lancer Orthodontics, Inc. | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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…(21 CFR 872.3640) 6. Legally Marketed Devices to which Substantial Equivalence is claimed: a. AbsoAnchor (Orthodontic Microimplant) - Dentos Incorporated (K060126) b. Lin/Lion Orthodontic Mini Anchor System (LOMAS) (Sterile) - Mondeal Medical Systems GmbH (K050257)… | 2006 |
| * | K050257 | Lin/Liou Orthodontic Mini Anchor System (Lomas) (Sterile)Summary page 1…Orthodontic Microimplant) - Dentos Incorporated (K060126) b. Lin/Lion Orthodontic Mini Anchor System (LOMAS) (Sterile) - Mondeal Medical Systems GmbH (K050257) c. Temporary Orthodontic Anchor - Ortho Organizers, Inc. (K061266) d. tomas (Temporary Orthodontic Micro Anchora… | 2005 |
| * | K061266 | Ortho Organizers Temporary Orthodontic AnchorSummary page 1…on Orthodontic Mini Anchor System (LOMAS) (Sterile) - Mondeal Medical Systems GmbH (K050257) c. Temporary Orthodontic Anchor - Ortho Organizers, Inc. (K061266) d. tomas (Temporary Orthodontic Micro Anchorage System) pins - Dentaurum (K042965) 7. Device Description… | 2006 |
| * | K042965 | Tomas PinSummary page 1…) c. Temporary Orthodontic Anchor - Ortho Organizers, Inc. (K061266) d. tomas (Temporary Orthodontic Micro Anchorage System) pins - Dentaurum (K042965) 7. Device Description: The Orthodontic TAADS Screws are single-use, screw-type, root-form endosseous dental i… | 2005 |
What descends from it? (2)
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?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K122069 (Lancer Orthodontics, Inc., 2013) has gone furthest, with 0 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. 2007, 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 Orthodontic TAADS Screws are intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. They are intended for temporary use and should 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/K063149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063149: Orthodontic Taads (Temporary Anatomical Anchor Device System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063149
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