510(k) · Cleared
ClearedOrtho Implant and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · OAT Implant, Endosseous, Orthodontic
Cleared on Sep 30, 1998 as substantially equivalent to K971578 (Straumann USA, 1997) and 3 other predicates after a 72-day review. Its family tree reaches back 2 generations to 1990. 66 later devices descend from it.
- Decided
- Sep 30, 1998
- Review
- 72 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K894844 (1990). 12 ancestors in all. 66 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 1 generation backK973353 Bonding BaseStraumann USA · 1997
- This deviceK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- Descendant · cites it directly · 63 of its ownK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- Descendant · cites it directly · 54 of its ownK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- Descendant · cites it directly · 26 of its ownK042965 Tomas PinDentaurum, Inc. · 2005
- Descendant · 2 generations on · 19 of its ownK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- Descendant · 3 generations on · 14 of its ownK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K031936Osteomed Orthodontic Screw SystemOsteomed LP · 2004 · cites it directly63descendants
- K033767Dual Top Anchor System ScrewsJeil Medical Corporation · 2004 · cites it directly54descendants
- K042965Tomas PinDentaurum, Inc. · 2005 · cites it directly26descendants
- K060126Absoanchor MicroimplantDentos, Inc. · 2006 · 2 generations on19descendants
- K071490Leone Orthodontic Mini ImplantLeone S.P.A. · 2008 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −1 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| 0 (this device) | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| +1 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| +1 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| +1 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| +2 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| +3 | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 9 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K971578 | Endosseous Dental ImplantSummary page 1…cation Name: Dental Implant (21 CFR 872.3640) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI SLA Dental Implant with Bonding Base (K971578, K973353) Nobel Biocare Onplant (K980460) Sendax Mini Dental Implant (K972351) 4. Description of the Device ' - The Ortho impla… | 1997 |
| * | K973353 | Bonding BaseSummary page 1…me: Dental Implant (21 CFR 872.3640) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI SLA Dental Implant with Bonding Base (K971578, K973353) Nobel Biocare Onplant (K980460) Sendax Mini Dental Implant (K972351) 4. Description of the Device ' - The Ortho implant is a s… | 1997 |
| * | K980460 | Onplant Orthodontic SystemSummary page 1…640) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI SLA Dental Implant with Bonding Base (K971578, K973353) Nobel Biocare Onplant (K980460) Sendax Mini Dental Implant (K972351) 4. Description of the Device ' - The Ortho implant is a solid one-piece, threaded, self-t… | 1998 |
| * | K972351 | Sendax Mdi (Mini Dental Implant)Summary page 1…which Equivalence is Claimed (Predicate Devices) ITI SLA Dental Implant with Bonding Base (K971578, K973353) Nobel Biocare Onplant (K980460) Sendax Mini Dental Implant (K972351) 4. Description of the Device ' - The Ortho implant is a solid one-piece, threaded, self-tapping design made from CP titanium,… | 1997 |
What descends from it? (66)
See all 666 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 8 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K031936 (Osteomed LP, 2004) has gone furthest, with 63 descendants of its own.
- 6 other devices also cite its predicate K971578.
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?
The Ortho implant of the Straumann Orthosystem is an endosseous implant
intended for placement in the median palatal region or in retromolar positions.
Its purpose is to provide a fixed anchorage point for attachment of orthodontic
appliances intended to facilitate the orthodontic movement of teeth. It is used
temporarily and is intended to be removed after orthodontic treatment has been
completed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982509: Ortho Implant and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982509
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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