510(k) Report

FDA product code · Dental

Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer

KXXClass I21 CFR 872.3450510(k) exempt1 decision since 19860 recalls

FDA lists KXX 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 1986. 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 KXX 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 · KXX

FDA has decided no KXX device since 2007.

Median 510(k) review, days · KXX

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

Recalls per year · KXX

No recall names KXX since 2007.

Adverse event reports per year · KXX

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code KXX, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—01
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 — KXX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KXX? 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 KXX lately?

The one KXX decision →

Related product codes

Other codes under 21 CFR 872.3450.

KOP Adhesive, Denture, Karaya