FDA product code · Dental

Light, Fiber Optic, Dental

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

EAYClass I21 CFR 872.4620510(k) exempt18 decisions since 19760 recalls

FDA lists EAY 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. 18 FDA decisions since 1976. 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 EAY 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 · EAY

FDA has decided no EAY device since 2007.

Median 510(k) review, days · EAY

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

Recalls per year · EAY

No recall names EAY since 2007.

Adverse event reports per year · EAY

1in 2013

2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code EAY, 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	—	1
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 — EAY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EAY? 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

Light, Fiber Optic, Dental

What has FDA decided in EAY lately?