FDA product code · Dental

Tip, Rubber, Oral Hygiene

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

JEWClass I21 CFR 872.6650510(k) exempt3 decisions since 19790 recalls

FDA lists JEW 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 JEW 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 · JEW

FDA has decided no JEW device since 2007.

Median 510(k) review, days · JEW

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

Recalls per year · JEW

No recall names JEW since 2007.

Adverse event reports per year · JEW

1in 2018

2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code JEW, 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	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	1
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in JEW? 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

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Tip, Rubber, Oral Hygiene

What has FDA decided in JEW lately?

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