510(k) · Cleared
ClearedOrthodontic Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · OAT Implant, Endosseous, Orthodontic
Cleared on Mar 25, 2011 as substantially equivalent to K062156 (Osstem Implant Co., Ltd., 2006) after a 156-day review. Its family tree reaches back 6 generations to 1990. 4 later devices descend from it.
- Decided
- Mar 25, 2011
- Review
- 156 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K894844 (1990). 17 ancestors in all. 4 later devices descend from it, 2 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 backK062156 Super Orthodontic ScrewOsstem Implant Co., Ltd. · 2006
- This deviceK103105 Orthodontic ScrewOsstem Implant Co., Ltd. · 2011
- Descendant · cites it directly · 2 of its ownK161197 Orthodontic ScrewOsstem Implant Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK231502 Mini ScrewsProimtech Saglik Urunleri Anonim Sirketi · 2024
- Descendant · cites it directly · 0 of its ownK211992 Ortho MI SystemOsteonic Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK190871 Bio-TackS Orthodontic Mini ImplantBiocetec Co., Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K161197Orthodontic ScrewOsstem Implant Co., Ltd. · 2016 · cites it directly2descendants
- K231502Mini ScrewsProimtech Saglik Urunleri Anonim Sirketi · 2024 · 2 generations on0descendants
- K211992Ortho MI SystemOsteonic Co., Ltd. · 2021 · cites it directly0descendants
- K190871Bio-TackS Orthodontic Mini ImplantBiocetec Co., Ltd. · 2020 · 2 generations on0descendants
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 | K062156 | Super Orthodontic Screw | Osstem Implant Co., Ltd. | 2006 | — |
| 0 (this device) | K103105 | Orthodontic Screw | Osstem Implant Co., Ltd. | 2011 | — |
| +1 | K161197 | Orthodontic Screw | Osstem Implant Co., Ltd. | 2016 | — |
| +2 | K231502 | Mini Screws | Proimtech Saglik Urunleri Anonim Sirketi | 2024 | — |
| +1 | K211992 | Ortho MI System | Osteonic Co., Ltd. | 2021 | — |
| +2 | K190871 | Bio-TackS Orthodontic Mini Implant | Biocetec 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062156 | Super Orthodontic ScrewSummary page 1…Class I OAT 3. Predicate Device The Super Orthodontic Screw System, OSSIEM Implant Co., Ltd, K062 156 4. Description The Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anch… | 2006 |
What descends from it? (4)
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 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K161197 (Osstem Implant Co., Ltd., 2016) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K062156.
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 Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is 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/K103105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103105: Orthodontic Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103105
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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