FDA applicant
Zirkonzahn Srl
FDA records 11 decisions for Zirkonzahn Srl (Gais, IT) from 2006 to 2023: 11 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and EBG (Crown And Bridge, Temporary, Resin). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 121 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Zirkonzahn GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zirkonzahn Srl’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Zirkonzahn Srl’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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