LO
CapabilityCognitive automation2022-05-10
The FDA cleared AI software that marks suspected tooth decay on bitewing X-rays, on the condition that trained dentists use it and make the diagnosis
Dentistoccupation page →
Event date / reported
2022-05-10
Evidence stage
CapabilityA demo, benchmark or paper shows the task can be done. Updates what the technology can do — not what employers will do.
Tasks this bears on
Reading dental X-rays
Looking at bitewing and other radiographs for decay, bone loss and other problems that are not visible in the mouth.
Being augmented✓ Evidence-backed
Where this applies
The regulator's clearance letter of 10 May 2022 with the device's indications for use and 510(k) summary, read in the full PDF. The software is cleared to aid in detecting and outlining caries on bitewing radiographs, providing additional information for the dentist; it is not intended as a replacement for a complete dentist's review or clinical judgement, should be used only by trained dentists, assists only in detection and not interpretation or diagnosis, and should not be the sole decision-making tool for diagnosis or treatment; final clinical determination is the treating clinician's. The summary reports the manufacturer's own testing: standalone sensitivity 72.0% and specificity 98.1% on 352 images; in a reader study with 13 US-licensed dentists, sensitivity rose from 57.9% unaided to 76.2% aided while specificity fell from 99.3% to 98.4%. It lists limits including decay hidden by restorations, gross decay and endodontic access mistaken for caries. It establishes what one tool may be sold to do and its manufacturer's reported performance; it is not a measure of use in practice, and a capability record moves nothing on this page.
What this means
The US regulator cleared AI that marks suspected decay on dental X-rays as an aid to trained dentists, not a replacement for their review or diagnosis.
What it does not yet show
It shows what the tool may be sold to do and its manufacturer's own study results; it does not show how many dentists use it or how it performs in everyday practice.
What you can check
If your practice uses an AI X-ray tool, find its clearance or approval and read the warnings and the cases it is not meant for.
Does it change the assessment?
No — and this stage does not move it either. A "Capability" record is real evidence, but it does not upgrade a task judgement on its own. The 1 linked judgement above stand where they were.
Source
US Food and Drug Administration — 510(k) K212519, Overjet Caries Assist (clearance letter and summary) · verified 2026-09-24 · Claude (VOLO agent) — source text fetched and cross-checked · interpreted 2026-09-24 · Claude (VOLO agent)
Primary source — published by the party that did this, or the authority of record. No co-signature needed.