510(k) Report

FDA product code · Dental

Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer

KXWClass I21 CFR 872.3410510(k) exempt0 decisions0 recalls

FDA lists KXW 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. 0 FDA decisions. 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 KXW 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 · KXW

FDA has decided no KXW device since 2007.

Median 510(k) review, days · KXW

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

Recalls per year · KXW

No recall names KXW since 2007.

Adverse event reports per year · KXW

1in 2012

2010: 12012: 1
2007high 1 (2010) · low 0 (2007)2025

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

Planning a device in KXW? 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

Related product codes

Other codes under 21 CFR 872.3410.

KOL Adhesive, Denture, Carboxymethylcellulose…KOQ Adhesive, Denture, Carboxymethylcellulose…