FDA product code · Dental

Kit, Test, In Vitro Periodontal

Name: FDA decisions, review times, recalls and adverse event reports for product code MCL
Creator: 510(k) Report

MCLClass IIIPMA required1 decision since 19900 recalls

1 FDA decision since 1990. 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 MCL 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 · MCL

FDA has decided no MCL device since 2007.

Median 510(k) review, days · MCL

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

Recalls per year · MCL

No recall names MCL since 2007.

Adverse event reports per year · MCL

No MAUDE report names MCL since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — MCL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MCL? 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

Kit, Test, In Vitro Periodontal

What has FDA decided in MCL lately?