FDA applicant
Vita Zahnfabrik H.Rauter GmbH & Co.
FDA records 13 decisions for Vita Zahnfabrik H.Rauter GmbH & Co. (Bad Sackingen, DE) from 2009 to 2026: 13 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and KLE (Agent, Tooth Bonding, Resin). Since 2016 its 510(k)s took a median of 174 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Vita Zahnfabrik GmbH H Rauter & CO”, “Vita Zahnfabrik H. Rauter GmbH & Co. Kg.”, “Vita Zahnfabrik H.Rauter GmbH Co.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vita Zahnfabrik H.Rauter GmbH & Co.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Vita Zahnfabrik H.Rauter GmbH & Co.’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 “Vita”
FDA records each applicant name separately; these may or may not be the same firm.