510(k) · Cleared
ClearedPSM Lomas / Benefit Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Psm Medical Solutions · OAT Implant, Endosseous, Orthodontic
Cleared on Dec 14, 2011 as substantially equivalent to K042345 (Mondeal Medical Systems GmbH, 2005) and 4 other predicates after a 306-day review. Its family tree reaches back 9 generations to 1990. 5 later devices descend from it.
- Decided
- Dec 14, 2011
- Review
- 306 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K894844 (1990). 24 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations between
- 3 generations backK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- 2 generations backK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- 1 generation backK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- This deviceK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
- Descendant · cites it directly · 3 of its ownK161335 Dual Top Screw SystemJeil Medical Corporation · 2017
- Descendant · cites it directly · 0 of its ownK242944 Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A. · 2025
- Descendant · 2 generations on · 0 of its ownK231913 T-FITTechwin Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK210559 ATOZ Mini-ScrewMk Meditech, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK191041 Orthodontic Fixation Screw [Smart Anchor Miniscrew]Gni Co., Ltd. · 2020
Show all 9 generations
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 8 generations backK973353 Bonding BaseStraumann USA · 1997
- 7 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 6 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 5 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 4 generations backK042965 Tomas PinDentaurum, Inc. · 2005
- 3 generations backK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- 2 generations backK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- 1 generation backK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- This deviceK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
Most influential descendants
Showing 5 of 5 · See all- K161335Dual Top Screw SystemJeil Medical Corporation · 2017 · cites it directly3descendants
- K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A. · 2025 · cites it directly0descendants
- K231913T-FITTechwin Co., Ltd. · 2024 · 2 generations on0descendants
- K210559ATOZ Mini-ScrewMk Meditech, Inc. · 2021 · 2 generations on0descendants
- K191041Orthodontic Fixation Screw [Smart Anchor Miniscrew]Gni Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −8 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −7 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −6 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −5 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −4 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| −3 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| −2 | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 2008 | — |
| −1 | K090476 | Syntec Orthodontic Mini Screw | Syntec Scientific Corp. | 2009 | — |
| 0 (this device) | K110392 | PSM Lomas / Benefit Screws | Psm Medical Solutions | 2011 | — |
| +1 | K161335 | Dual Top Screw System | Jeil Medical Corporation | 2017 | — |
| +1 | K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. | 2025 | — |
| +2 | K231913 | T-FIT | Techwin Co., Ltd. | 2024 | — |
| +2 | K210559 | ATOZ Mini-Screw | Mk Meditech, Inc. | 2021 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K042345 | Lin/Liou Orthodontic Mini Anchor System (Lomas)Summary page 1…l implant Ciasslication name:Endosseous dental implant, Dental -21 CFR 872.3640 Product Code: OAT Predicate Devices: - Lin/Liou Orthodontic Mini Anchor System (LOMAS) K042345 and Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) K050257 - manufactured by: Mondeal Medical Systems GmbH. - Syntec… | 2005 |
| * | K050257 | Lin/Liou Orthodontic Mini Anchor System (Lomas) (Sterile)Summary page 1…R 872.3640 Product Code: OAT Predicate Devices: - Lin/Liou Orthodontic Mini Anchor System (LOMAS) K042345 and Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) K050257 - manufactured by: Mondeal Medical Systems GmbH. - Syntec Orthodontic Mini Screws K090476 manufactured by Syntec Sci… | 2005 |
| * | K090476 | Syntec Orthodontic Mini ScrewSummary page 1…(LOMAS) K042345 and Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) K050257 - manufactured by: Mondeal Medical Systems GmbH. - Syntec Orthodontic Mini Screws K090476 manufactured by Syntec Scientific Corporation - IMTEC Sendax MDI ORTHO K023067 made by IMTEC Corporation -… | 2009 |
| * | K023067 | Imtec Sendax Mdi ORTHO6 and ORTHO8Summary page 1…d by: Mondeal Medical Systems GmbH. - Syntec Orthodontic Mini Screws K090476 manufactured by Syntec Scientific Corporation - IMTEC Sendax MDI ORTHO K023067 made by IMTEC Corporation - MDI ORTHO K042289 made by IMTEC Corporation… | 2002 |
| * | K042289 | Mdi OrthoSummary page 1…rthodontic Mini Screws K090476 manufactured by Syntec Scientific Corporation - IMTEC Sendax MDI ORTHO K023067 made by IMTEC Corporation - MDI ORTHO K042289 made by IMTEC Corporation 1/2 510(10 Sumnmar… | 2004 |
What descends from it? (5)
2 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 21 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- None of the 24 ancestors has a recall.
- Of its descendants, K161335 (Jeil Medical Corporation, 2017) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K042345.
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 PSM LOMAS / BENEFIT Screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110392: PSM Lomas / Benefit Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110392
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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