510(k) · Cleared
ClearedOrtho Easy Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Forestadent Bernhard Forster GmbH · OAT Implant, Endosseous, Orthodontic
Cleared on Jun 3, 2011 as substantially equivalent to K062733 (Dentaurum, 2006) and 1 other predicate after a 123-day review. Its family tree reaches back 6 generations to 1990. 1 later device descends from it.
- Decided
- Jun 3, 2011
- Review
- 123 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K894844 (1990). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations backK973353 Bonding BaseStraumann USA · 1997
- 4 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 3 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 2 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 1 generation backK062733 Tomas Pin SD 6, 8, and 10 MMDentaurum · 2006
- This deviceK110275 Ortho Easy PinForestadent Bernhard Forster GmbH · 2011
- Descendant · cites it directly · 0 of its ownK260268 OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.) · 2026
Most influential descendants
Showing 1 of 1 · See all- K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.) · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −5 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −4 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −3 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −2 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −1 | K062733 | Tomas Pin SD 6, 8, and 10 MM | Dentaurum | 2006 | — |
| 0 (this device) | K110275 | Ortho Easy Pin | Forestadent Bernhard Forster GmbH | 2011 | — |
| +1 | K260268 | OrthoEasy Pal; OrthoEasy Pal Long Neck | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | 2026 | — |
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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K062733 | Tomas Pin SD 6, 8, and 10 MMSummary page 2…lengths (6, 8, 10, 12 mm), diameter 1,7 mm, and supplied in sealed polyethylene bags. Predicate Device: Tomas PIN (K062733), Dentaurum; Dual Top Anchor System Screws (K033767), Jeil Medical Corporat… | 2006 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 2…supplied in sealed polyethylene bags. Predicate Device: Tomas PIN (K062733), Dentaurum; Dual Top Anchor System Screws (K033767), Jeil Medical Corporation Substantial Equivalence: All reports show that the Ortho Easy Pin is… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260268 | OrthoEasy Pal; OrthoEasy Pal Long Neck | 2026 | 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 21 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K260268 (Bernhard Förster GmbH (Bernhard Foerster Ltd.), 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K062733.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 device is intended to provide a fix anchorage point for attachment of orthodontic appliance to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended to be single used only-
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110275: Ortho Easy Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110275
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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