510(k) · Cleared
ClearedC Type, CT Type, and Special Type Orthodontic Anchor Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomaterials Korea, Inc. · OAT Implant, Endosseous, Orthodontic
Cleared on Jul 26, 2007 after a 248-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Jul 26, 2007
- Review
- 248 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK063495 C Type, CT Type, and Special Type Orthodontic Anchor ScrewsBiomaterials Korea, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK161335 Dual Top Screw SystemJeil Medical Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK231913 T-FITTechwin Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK222245 ACR Screw SystemBiomaterials Korea, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK202691 Ortholock Anchorage DevicesCraniofacial Technologies, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK210559 ATOZ Mini-ScrewMk Meditech, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161335Dual Top Screw SystemJeil Medical Corporation · 2017 · cites it directly3descendants
- K231913T-FITTechwin Co., Ltd. · 2024 · 2 generations on0descendants
- K222245ACR Screw SystemBiomaterials Korea, Inc. · 2023 · cites it directly0descendants
- K202691Ortholock Anchorage DevicesCraniofacial Technologies, Inc. · 2022 · cites it directly0descendants
- K210559ATOZ Mini-ScrewMk Meditech, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063495 | C Type, CT Type, and Special Type Orthodontic Anchor Screws | Biomaterials Korea, Inc. | 2007 | — |
| +1 | K161335 | Dual Top Screw System | Jeil Medical Corporation | 2017 | — |
| +2 | K231913 | T-FIT | Techwin Co., Ltd. | 2024 | — |
| +1 | K222245 | ACR Screw System | Biomaterials Korea, Inc. | 2023 | — |
| +1 | K202691 | Ortholock Anchorage Devices | Craniofacial Technologies, Inc. | 2022 | — |
| +2 | K210559 | ATOZ Mini-Screw | Mk Meditech, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
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?
- Of its descendants, K161335 (Jeil Medical Corporation, 2017) has gone furthest, with 3 descendants of its own.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 C Type, CT Type and Special Type Orthodontic Anchor Screws are intended for use as a temporary anchor for orthodontic treatment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K063495 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063495: C Type, CT Type, and Special Type Orthodontic Anchor Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063495
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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