510(k) Report

FDA product code · Dental

Applicator, Rapid Wax, Dental

EITClass II21 CFR 872.3060510(k) exempt1 decision since 19900 recalls

FDA lists EIT 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. 1 FDA decision since 1990. 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 EIT 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 · EIT

FDA has decided no EIT device since 2007.

Median 510(k) review, days · EIT

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

Recalls per year · EIT

No recall names EIT since 2007.

Adverse event reports per year · EIT

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

Planning a device in EIT? 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 EIT lately?

  • K904467Argilite 3Argen Precious Metals, Inc. · 1990

The one EIT decision →

Related product codes

Other codes under 21 CFR 872.3060.

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