510(k) Report

FDA product code · Dental

Ink, Arch Tracing

KZOClass I21 CFR 872.3150510(k) exempt2 decisions since 19770 recalls

FDA lists KZO 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. 2 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 KZO 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 · KZO

FDA has decided no KZO device since 2007.

Median 510(k) review, days · KZO

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

Recalls per year · KZO

No recall names KZO since 2007.

Adverse event reports per year · KZO

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

Planning a device in KZO? 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 KZO lately?

  • K810972The Gnathometer-MBauer, Cheng & Associates, Inc. · 1981
  • K771176Gothic Arch TracingDentsply Intl. · 1977

All 2 KZO decisions →

Related product codes

Other codes under 21 CFR 872.3150.

EJP Articulators