FDA product code · Dental

Point, Silver, Endodontic

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

EKLClass I21 CFR 872.3840510(k) exempt3 decisions since 19820 recalls

FDA lists EKL 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 1982. 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 EKL 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 · EKL

FDA has decided no EKL device since 2007.

Median 510(k) review, days · EKL

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

Recalls per year · EKL

No recall names EKL since 2007.

Adverse event reports per year · EKL

No MAUDE report names EKL 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 — EKL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EKL? 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

Point, Silver, Endodontic

Which EKL devices have the deepest lineage?

What has FDA decided in EKL lately?