510(k) Report

FDA applicant

Dental Monitoring Sas

Paris, FR1 decision2024–20240 recalls

FDA records 1 decision for Dental Monitoring Sas (Paris, FR) in 2024: 1 De Novo grant. All are in product code SBC (Dental Image Analyzer). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Dental Monitoring Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Dental Monitoring Sas by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dental Monitoring Sas’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • SBCDental Image Analyzer1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN230035DentalMonitoringDental Monitoring Sas · 20241cites it

What has FDA decided for it lately?

  • DEN230035DentalMonitoringDental Monitoring Sas · 2024

The one decision as Dental Monitoring Sas →