FDA applicant
Synapse Dental
FDA records 3 decisions for Synapse Dental (Cranston, RI) from 2019 to 2020: 3 510(k) clearances. All are in product code LWM (Device, Electrical Dental Anesthesia). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Synapse Dental, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Synapse Dental’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Synapse Dental’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 “Synapse”
FDA records each applicant name separately; these may or may not be the same firm.