510(k) · Cleared
ClearedTomas Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentaurum, Inc. · OAT Implant, Endosseous, Orthodontic
Cleared on Apr 15, 2005 as substantially equivalent to K031936 (Osteomed LP, 2004) and 3 other predicates after a 170-day review. Its family tree reaches back 5 generations to 1990. 26 later devices descend from it.
- Decided
- Apr 15, 2005
- Review
- 170 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K894844 (1990). 16 ancestors in all. 26 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 4 generations backK973353 Bonding BaseStraumann USA · 1997
- 3 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 2 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 1 generation backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- This deviceK042965 Tomas PinDentaurum, Inc. · 2005
- Descendant · cites it directly · 19 of its ownK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- Descendant · 2 generations on · 14 of its ownK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- Descendant · 3 generations on · 13 of its ownK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- Descendant · 4 generations on · 5 of its ownK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
- Descendant · cites it directly · 4 of its ownK052471 HDC Spider ScrewHdc S.R.L. · 2005
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K060126Absoanchor MicroimplantDentos, Inc. · 2006 · cites it directly19descendants
- K071490Leone Orthodontic Mini ImplantLeone S.P.A. · 2008 · 2 generations on14descendants
- K090476Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009 · 3 generations on13descendants
- K110392PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011 · 4 generations on5descendants
- K052471HDC Spider ScrewHdc S.R.L. · 2005 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −4 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −3 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −2 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −1 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| 0 (this device) | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| +1 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| +2 | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 2008 | — |
| +3 | K090476 | Syntec Orthodontic Mini Screw | Syntec Scientific Corp. | 2009 | — |
| +4 | K110392 | PSM Lomas / Benefit Screws | Psm Medical Solutions | 2011 | — |
| +1 | K052471 | HDC Spider Screw | Hdc S.R.L. | 2005 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K031936 | Osteomed Orthodontic Screw SystemSummary page 1…Ortho (2) Equivalent legally marketed devices: OsteoMed Orthodontic Screw System (K03 1936), Straumann and the Jeil Medical Impl… | 2004 |
| * | K982509 | Ortho Implant and AccessoriesSummary page 1…Orthodontic Screw System (K03 1936), Straumann and the Jeil Medical Implant (K982509), Nobel Biocare Implant Orthodontic Anchor System (K000643), Corporation Dual Top Anchor System Screws (K033767)..… | 1998 |
| * | K000643 | Inplant Orthodontic Anchor SystemSummary page 1…and the Jeil Medical Implant (K982509), Nobel Biocare Implant Orthodontic Anchor System (K000643), Corporation Dual Top Anchor System Screws (K033767)..… | 2000 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 1…and the Jeil Medical Implant (K982509), Nobel Biocare Implant Orthodontic Anchor System (K000643), Corporation Dual Top Anchor System Screws (K033767).. the treatment of (3… | 2004 |
What descends from it? (26)
See all 267 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060126 | Absoanchor Microimplant | 2006 | 19 |
| K052471 | HDC Spider Screw | 2005 | 4 |
| K063149 | Orthodontic Taads (Temporary Anatomical Anchor Device System) | 2007 | 2 |
| K062367 | Miniscrews Anchoring System, M.a.S. | 2006 | 1 |
| K120861 | Fin-S Microimplant | 2013 | 0 |
| K081393 | Orthodontic Temporary Anchorage Implant Screw | 2008 | 0 |
| K072917 | JJG Evolution Orthodontic Implant System | 2008 | 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 15 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K060126 (Dentos, Inc., 2006) has gone furthest, with 19 descendants of its own.
- 7 other devices also cite its predicate K031936.
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?
Temporary Orthodontic Micro Anchorage
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042965: Tomas Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042965
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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