510(k) Report

FDA product code · Dental

Implant, Transmandibular

MDLClass II21 CFR 872.4760510(k) required2 decisions since 19850 recalls

2 FDA decisions since 1985. 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 MDL 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 · MDL

FDA has decided no MDL device since 2007.

Median 510(k) review, days · MDL

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

Recalls per year · MDL

No recall names MDL since 2007.

Adverse event reports per year · MDL

2in 2013

2013: 2
2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code MDL, 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—02
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 — MDL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MDL? 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 872.4760.