FDA product code · Dental

Tray, Fluoride, Disposable

Name: FDA decisions, review times, recalls and adverse event reports for product code KMT
Creator: 510(k) Report

KMTClass I21 CFR 872.6870510(k) exempt8 decisions since 19770 recalls

FDA lists KMT 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 1977. No recall names this code. The most-cited predicate is K811154, named by 1 later device.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, dental panel

Twenty years of KMT 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 · KMT

FDA has decided no KMT device since 2007.

Median 510(k) review, days · KMT

Too few KMT 510(k)s in any year since 2007 to give a median.

Recalls per year · KMT

No recall names KMT since 2007.

Adverse event reports per year · KMT

1in 2014

2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code KMT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	1
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — KMT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KMT? 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) Report

Tray, Fluoride, Disposable

Which predicates do KMT devices cite most?

Which KMT devices have the deepest lineage?

What has FDA decided in KMT lately?