510(k) Report

FDA product code · Dental

Cushion, Denture, Over The Counter

EHSClass II21 CFR 872.3540510(k) exempt3 decisions since 19770 recalls

FDA lists EHS 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 1977. 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 EHS 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 · EHS

FDA has decided no EHS device since 2007.

Median 510(k) review, days · EHS

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

Recalls per year · EHS

No recall names EHS since 2007.

Adverse event reports per year · EHS

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

Planning a device in EHS? 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 EHS lately?

  • K971002Smile with ConfidenceLloyd V. Ziemendorf · 1997
  • K813190Soft Plate CushionLeonard Russo Co. · 1982
  • K770413Cushions, Denture Adhesive, All-DayCombe, Inc. · 1977

All 3 EHS decisions →

Related product codes

Other codes under 21 CFR 872.3540.

NKJ Cushion, Pad, Denture, Wax Impregnated Cotton…EHR Pad, Denture, Over The Counter