510(k) Report

FDA product code · Dental

Clasp, Wire

EJWClass I21 CFR 872.3285510(k) exempt3 decisions since 19870 recalls

FDA lists EJW 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 1987. 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 EJW 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 · EJW

FDA has decided no EJW device since 2007.

Median 510(k) review, days · EJW

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

Recalls per year · EJW

No recall names EJW since 2007.

Adverse event reports per year · EJW

No MAUDE report names EJW since 2007.

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

Planning a device in EJW? 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

What has FDA decided in EJW lately?

  • K901257Wirontom Clasp WireIvoclar North America, Inc. · 1990
  • K881331Orthodontic Nitinol SpringsFlexmedics · 1988
  • K872746Vitallium WireAustenal Dental, Inc. · 1987

All 3 EJW decisions →

Related product codes

Other codes under 21 CFR 872.3285.

EHP Clasp, Preformed