FDA applicant
Biotech Dental, Sas
FDA records 4 decisions for Biotech Dental, Sas (Salon De Provence, FR) from 2021 to 2024: 4 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 136 days from receipt to decision, against 204 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Biotech Dental, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biotech Dental, Sas’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Biotech Dental, Sas’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) ReportOther applicant names beginning “Biotech”
FDA records each applicant name separately; these may or may not be the same firm.