FDA product code · Dental

Applicator, Resin

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

KXRClass I21 CFR 872.3140510(k) exempt3 decisions since 19770 recalls

FDA lists KXR 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. 3 FDA decisions since 1977. No recall names this code.

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 KXR 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 · KXR

FDA has decided no KXR device since 2007.

Median 510(k) review, days · KXR

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

Recalls per year · KXR

No recall names KXR since 2007.

Adverse event reports per year · KXR

No MAUDE report names KXR since 2007.

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	—	0
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 — KXR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KXR? 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

Applicator, Resin

What has FDA decided in KXR lately?