FDA product code · Dental

Intraoral Camera

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

QJKClass II21 CFR 872.3661510(k) exempt0 decisions0 recalls

FDA lists QJK 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. 0 FDA decisions. No recall names this code.

To capture the topographical characteristics of teeth or a stone model

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 QJK 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.

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

Planning a device in QJK? 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

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