FDA applicant
S & C Polymer GmbH
FDA records 20 decisions for S & C Polymer GmbH (Elmshorn, DE) from 1995 to 2009: 20 510(k) clearances. Most are in product codes EMA (Cement, Dental) and EBF (Material, Tooth Shade, Resin). Its devices cite 4 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided S & C Polymer GmbH’s devices, and how often a recall has named them.
FDA decisions per year
4in 2009
2026 so far, outlined.
Recalls per year
2in 2014
Class I Class II/III not classified
Planning a device like S & C Polymer GmbH’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