510(k) · Cleared
ClearedDual Top Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Medical Corporation · OAT Implant, Endosseous, Orthodontic
Cleared on Feb 23, 2017 as substantially equivalent to K063495 (Biomaterials Korea, Inc., 2007) and 1 other predicate after a 287-day review. Its family tree reaches back 10 generations to 1990. 3 later devices descend from it.
- Decided
- Feb 23, 2017
- Review
- 287 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K894844 (1990). 26 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 6 generations between
- 3 generations backK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- 2 generations backK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- 1 generation backK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
- This deviceK161335 Dual Top Screw SystemJeil Medical Corporation · 2017
- Descendant · cites it directly · 0 of its ownK231913 T-FITTechwin Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK210559 ATOZ Mini-ScrewMk Meditech, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK191041 Orthodontic Fixation Screw [Smart Anchor Miniscrew]Gni Co., Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 9 generations backK973353 Bonding BaseStraumann USA · 1997
- 8 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 7 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 6 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 5 generations backK042965 Tomas PinDentaurum, Inc. · 2005
- 4 generations backK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- 3 generations backK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- 2 generations backK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- 1 generation backK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
- This deviceK161335 Dual Top Screw SystemJeil Medical Corporation · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −9 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −8 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −7 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −6 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −5 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| −4 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| −3 | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 2008 | — |
| −2 | K090476 | Syntec Orthodontic Mini Screw | Syntec Scientific Corp. | 2009 | — |
| −1 | K110392 | PSM Lomas / Benefit Screws | Psm Medical Solutions | 2011 | — |
| 0 (this device) | K161335 | Dual Top Screw System | Jeil Medical Corporation | 2017 | — |
| +1 | K231913 | T-FIT | Techwin Co., Ltd. | 2024 | — |
| +1 | K210559 | ATOZ Mini-Screw | Mk Meditech, Inc. | 2021 | — |
| +1 | K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | Gni Co., Ltd. | 2020 | — |
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 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K063495 | C Type, CT Type, and Special Type Orthodontic Anchor ScrewsSummary page 5…te Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; • Primary Predicate: K063495 • Applicant: Biomaterials Korea, Incorporated • Common Name:… | 2007 |
| * | K110392 | PSM Lomas / Benefit ScrewsSummary page 5…lant, Endosseous, Orthodontic • Device Name: The C-Type, CT Type and Special Type • Reference Predicate: K110392 • Applicant: PSM MEDICAL SOLUTIONS • Common Name: Impla… | 2011 |
What descends from it? (3)
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 27 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K231913 (Techwin Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K063495.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Dual Top Screw System is intended for use as a temporary anchor for orthodontic treatment for use in patients aged 12 and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161335 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161335: Dual Top Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161335
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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