FDA applicant
Union Dental S.A.
FDA records 1 decision for Union Dental S.A. (Tielmes, ES) in 2015: 1 510(k) clearance. All are in product code EBG (Crown And Bridge, Temporary, Resin). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Union Dental S.A.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Union Dental S.A.’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 “Union”
FDA records each applicant name separately; these may or may not be the same firm.