FDA applicant
Wieland Dental + Technik GmbH & Co. KG
FDA records 45 decisions for Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE) from 2002 to 2015: 45 510(k) clearances. Most are in product codes EJT (Alloy, Gold-Based Noble Metal) and EIH (Powder, Porcelain). Its devices cite 46 predicates, 5 of them its own earlier devices. 22 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Wieland Dental + Technik GmbH & Co. KG’s devices, and how often a recall has named them.
FDA decisions per year
3in 2015
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Wieland Dental + Technik GmbH & Co. KG’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 “Wieland”
FDA records each applicant name separately; these may or may not be the same firm.