510(k) · Cleared
ClearedOrthoEasy Pal; OrthoEasy Pal Long Neck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bernhard Förster GmbH (Bernhard Foerster Ltd.) · OAT Implant, Endosseous, Orthodontic
Cleared on May 19, 2026 as substantially equivalent to K110275 (Forestadent Bernhard Forster GmbH, 2011) after a 111-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- May 19, 2026
- Review
- 111 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894844 (1990). 18 ancestors in all. No later device cites it as a predicate yet.
- 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 backK062733 Tomas Pin SD 6, 8, and 10 MMDentaurum · 2006
- 1 generation backK110275 Ortho Easy PinForestadent Bernhard Forster GmbH · 2011
- This deviceK260268 OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.) · 2026
View 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 | K062733 | Tomas Pin SD 6, 8, and 10 MM | Dentaurum | 2006 | — |
| −1 | K110275 | Ortho Easy Pin | Forestadent Bernhard Forster GmbH | 2011 | — |
| 0 (this device) | 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 |
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 K242944 Leone Orthodontic Implant TAD (Temporary…score 12.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
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 36 years and passes through 7 companies; a new generation was cleared every 4.6 years on median.
- None of the 18 ancestors has a recall.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
FORESTADENT OrthoEasy® anchorage screws are intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only.
The device is not intended for palatal expansion or for use as a prosthodontic or dental implant component.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260268: OrthoEasy Pal; OrthoEasy Pal Long Neck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260268
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026