FDA product code · Dental

Teeth, Preformed Gold Denture

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

ELNClass I21 CFR 872.3580510(k) exempt1 decision since 19770 recalls

FDA lists ELN 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. 1 FDA decision 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 ELN 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 · ELN

FDA has decided no ELN device since 2007.

Median 510(k) review, days · ELN

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

Recalls per year · ELN

No recall names ELN since 2007.

Adverse event reports per year · ELN

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

Planning a device in ELN? 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

Teeth, Preformed Gold Denture

What has FDA decided in ELN lately?