FDA product code · Dental

Coating, Denture Hydrophilic, Resin

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

EBEClass II21 CFR 872.3300510(k) exempt3 decisions since 19790 recalls

FDA lists EBE 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 1979. 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 EBE 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 · EBE

FDA has decided no EBE device since 2007.

Median 510(k) review, days · EBE

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

Recalls per year · EBE

No recall names EBE since 2007.

Adverse event reports per year · EBE

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

Planning a device in EBE? 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

Coating, Denture Hydrophilic, Resin

What has FDA decided in EBE lately?