FDA applicant
Dent4you AG
FDA records 5 decisions for Dent4you AG (Heerbrugg, CH) from 2022 to 2026: 5 510(k) clearances. Most are in product codes ELW (Material, Impression) and ELC (Scaler, Ultrasonic). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Dent4You AG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dent4you AG’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Dent4you AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report