510(k) · Cleared
ClearedPower Coins Glow in the Dark Ligatures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Kinetics Corp. · ECI Band, Elastic, Orthodontic
Cleared on Apr 20, 1998 after a 46-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 20, 1998
- Review
- 46 days
- Class
- Class I
- Product code
- ECI
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 ECI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All ECI devicesECI Band, Elastic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ECI
FDA has decided no ECI device since 2007.
Median 510(k) review, days · ECI
Too few ECI 510(k)s in any year since 2007 to give a median.
Recalls per year · ECI
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ECI
1in 2024
MAUDE reports naming product code ECI, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 2 to 4 weeks when they are replaced.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980864 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980864: Power Coins Glow in the Dark Ligatures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980864
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026