510(k) · Cleared
ClearedTomas Pin SD 6, 8, and 10 MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentaurum · OAT Implant, Endosseous, Orthodontic
Cleared on Nov 9, 2006 as substantially equivalent to K031936 (Osteomed LP, 2004) and 3 other predicates after a 57-day review. Its family tree reaches back 5 generations to 1990. 6 later devices descend from it.
- Decided
- Nov 9, 2006
- Review
- 57 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. 6 later devices descend from it, 3 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 deviceK062733 Tomas Pin SD 6, 8, and 10 MMDentaurum · 2006
- Descendant · cites it directly · 2 of its ownK071851 HDC Sterile Spider ScrewHdc S.R.L. · 2007
- Descendant · cites it directly · 1 of its ownK110275 Ortho Easy PinForestadent Bernhard Forster GmbH · 2011
- Descendant · 2 generations on · 0 of its ownK260268 OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.) · 2026
- Descendant · 2 generations on · 0 of its ownK122069 Storm Mini ScrewLancer Orthodontics, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK091390 HDC Sterile Self Ligating Spider Screw, Model Sli,SL2Hdc S.R.L. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071851HDC Sterile Spider ScrewHdc S.R.L. · 2007 · cites it directly2descendants
- K110275Ortho Easy PinForestadent Bernhard Forster GmbH · 2011 · cites it directly1descendant
- K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.) · 2026 · 2 generations on0descendants
- K122069Storm Mini ScrewLancer Orthodontics, Inc. · 2013 · 2 generations on0descendants
- K091390HDC Sterile Self Ligating Spider Screw, Model Sli,SL2Hdc S.R.L. · 2009 · 2 generations on0descendants
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) | K062733 | Tomas Pin SD 6, 8, and 10 MM | Dentaurum | 2006 | — |
| +1 | K071851 | HDC Sterile Spider Screw | Hdc S.R.L. | 2007 | — |
| +1 | K110275 | Ortho Easy Pin | Forestadent Bernhard Forster GmbH | 2011 | — |
| +2 | K260268 | OrthoEasy Pal; OrthoEasy Pal Long Neck | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | 2026 | — |
| +2 | K122069 | Storm Mini Screw | Lancer Orthodontics, Inc. | 2013 | — |
| +2 | K091390 | HDC Sterile Self Ligating Spider Screw, Model Sli,SL2 | Hdc S.R.L. | 2009 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2026 | 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…sification Name: Implant, Endosseous, Product Code DZE Common/Usual Name: Bone Screw (2) Equivalent legally marketed devices: OsteoMed Orthodontic Screw System (K03 1936), Straumann Ortho Implant (K982509), Nobel Biocare Implant Orthodontic Anchor System (K000643), and the Jeil Medical… | 2004 |
| * | K982509 | Ortho Implant and AccessoriesSummary page 1…uct Code DZE Common/Usual Name: Bone Screw (2) Equivalent legally marketed devices: OsteoMed Orthodontic Screw System (K03 1936), Straumann Ortho Implant (K982509), Nobel Biocare Implant Orthodontic Anchor System (K000643), and the Jeil Medical Corporation Dual Top Anchor System Screws… | 1998 |
| * | K000643 | Inplant Orthodontic Anchor SystemSummary page 1…ivalent legally marketed devices: OsteoMed Orthodontic Screw System (K03 1936), Straumann Ortho Implant (K982509), Nobel Biocare Implant Orthodontic Anchor System (K000643), and the Jeil Medical Corporation Dual Top Anchor System Screws (K033767).. (3) Indications for Use (intended use): Tom… | 2000 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 1…Straumann Ortho Implant (K982509), Nobel Biocare Implant Orthodontic Anchor System (K000643), and the Jeil Medical Corporation Dual Top Anchor System Screws (K033767).. (3) Indications for Use (intended use): Tomas-pins are temporary, enossal anchorage point for attachment of orthodont… | 2004 |
What descends from it? (6)
3 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 16 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K071851 (Hdc S.R.L., 2007) has gone furthest, with 2 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?
To provide a fixed anchorage point for attachment of
orthodontic appliances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062733 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062733: Tomas Pin SD 6, 8, and 10 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062733
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