FDA product code · Dental
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
FDA lists KOT as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 872.9 applies, such as a new intended use or a different fundamental technology. 8 FDA decisions since 1983. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of KOT at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · KOT
FDA has decided no KOT device since 2007.
Median 510(k) review, days · KOT
Too few KOT 510(k)s in any year since 2007 to give a median.
Recalls per year · KOT
No recall names KOT since 2007.
Adverse event reports per year · KOT
3in 2025
MAUDE reports naming product code KOT, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 31 |
| 2016 | 0 | — | 0 | 119 |
| 2017 | 0 | — | 0 | 82 |
| 2018 | 0 | — | 0 | 95 |
| 2019 | 0 | — | 0 | 54 |
| 2020 | 0 | — | 0 | 90 |
| 2021 | 0 | — | 0 | 88 |
| 2022 | 0 | — | 0 | 51 |
| 2023 | 0 | — | 0 | 71 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
Planning a device in KOT? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 872.3490.