510(k) Report

FDA product code · Dental

Alloy, Amalgam

EJJClass II21 CFR 872.3070510(k) required74 decisions since 19761 recall

74 FDA decisions since 1976. 1 recall names this code; it is not Class I. The most-cited predicate is K902249, named by 1 later device.

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 EJJ 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 · EJJ

FDA has decided no EJJ device since 2007.

Median 510(k) review, days · EJJ

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

Recalls per year · EJJ

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EJJ

2in 2021

2007: 492008: 92009: 52010: 222011: 82012: 12013: 12014: 52015: 42016: 22018: 32019: 12020: 12021: 2
2007high 49 (2007) · low 0 (2017)2025

MAUDE reports naming product code EJJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—049
20080—09
20090—05
20100—022
20110—08
20120—01
20130—01
20140—05
20150—04
20160—02
20170—00
20180—03
20190—01
20200—01
20210—02
20220—00
20230—10
20240—00
20250—00
20260—0—
FIG. 1 — EJJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EJJ? 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 872.3070.