FDA applicant
Schutz-Dental GmbH
FDA records 6 decisions for Schutz-Dental GmbH (Rosbach, DE) from 2005 to 2016: 6 510(k) clearances. Most are in product codes KLE (Agent, Tooth Bonding, Resin) and EIH (Powder, Porcelain). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Schutz Dental GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Schutz-Dental GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Schutz-Dental 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