510(k) Report

FDA product code · Dental

Lock, Wire, And Ligature, Intraoral

DYXClass II21 CFR 872.4600510(k) required11 decisions since 19820 recalls

11 FDA decisions since 1982. No recall names this code. The most-cited predicate is K820944, named by 4 later devices.

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 DYX 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 · DYX

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYX

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

Recalls per year · DYX

No recall names DYX since 2007.

Adverse event reports per year · DYX

1in 2016

2012: 22016: 1
2007high 2 (2012) · low 0 (2007)2025

MAUDE reports naming product code DYX, 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—02
20130—00
20140—00
20150—00
20160—01
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — DYX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DYX? 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