510(k) Report

FDA product code · Dental

Solution, Cold Sterilizing

LFEClass II21 CFR 880.6885510(k) required1 decision since 19830 recalls

1 FDA decision since 1983. 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 LFE 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 · LFE

FDA has decided no LFE device since 2007.

Median 510(k) review, days · LFE

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

Recalls per year · LFE

No recall names LFE since 2007.

Adverse event reports per year · LFE

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

Planning a device in LFE? 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 LFE lately?

  • K830106UnicideNorth Pacific Dental, Inc. · 1983

The one LFE decision →

Related product codes

Other codes under 21 CFR 880.6885.

MED Sterilant, Medical Devices