FDA product code · Dental

Cleaner, Denture, Mechanical

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

JERClass I21 CFR 872.3530510(k) exempt14 decisions since 19780 recalls

FDA lists JER 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 1978. 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 JER 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 · JER

FDA has decided no JER device since 2007.

Median 510(k) review, days · JER

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

Recalls per year · JER

No recall names JER since 2007.

Adverse event reports per year · JER

2in 2013

2007high 2 (2013) · low 0 (2008)2025

MAUDE reports naming product code JER, 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	—	1
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	0
2013	—	2
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 — JER by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JER? 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

Cleaner, Denture, Mechanical

What has FDA decided in JER lately?