510(k) Report

FDA product code · Dental

Light-Induced Fluorescence Caries Detector

NBLClass II21 CFR 872.1745510(k) required24 decisions since 20000 recalls

24 FDA decisions since 2000. 510(k) reviews decided 2021–2025 took a median of 323 days (half between 260 and 392). No recall names this code. The most-cited predicate is DEN990002, named by 8 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 NBL 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 · NBL

1in 2025

2007: 12009: 22010: 22011: 12012: 22013: 12016: 12017: 12018: 12020: 12022: 12023: 12024: 22025: 12026 (partial year): 1
2007high 2 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBL

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

Recalls per year · NBL

No recall names NBL since 2007.

Adverse event reports per year · NBL

1in 2020

2015: 12016: 12017: 12020: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code NBL, 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
20071—00
20080—00
20092—00
20102—00
20111—00
20122—00
20131—00
20140—00
20150—01
20161—01
20171—01
20181—00
20190—00
20201—01
20210—00
20221—00
20231—00
20242—00
20251—00
20261—0—
FIG. 1 — NBL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NBL? 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 872.1745.