FDA product code · Dental

Cotton, Roll

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

EFNClass I21 CFR 872.6050510(k) exempt14 decisions since 19770 recalls

FDA lists EFN 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. 14 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 EFN 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 · EFN

FDA has decided no EFN device since 2007.

Median 510(k) review, days · EFN

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

Recalls per year · EFN

No recall names EFN since 2007.

Adverse event reports per year · EFN

1in 2018

2007high 2 (2010) · low 0 (2007)2025

MAUDE reports naming product code EFN, 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	—	2
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	2
2016	—	0
2017	—	0
2018	—	1
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in EFN? 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

Related product codes

Other codes under 21 CFR 872.6050.

KHR Absorber, Saliva, Paper

Cotton, Roll

What has FDA decided in EFN lately?

Related product codes