FDA applicant
Ivoclar Vivadent, Inc.
FDA records 97 decisions for Ivoclar Vivadent, Inc. (Amherst, NY) from 2001 to 2026: 97 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). Since 2016 its 510(k)s took a median of 130 days from receipt to decision, against 153 for FDA’s reviews in the same codes and years. Its devices cite 45 predicates, 24 of them its own earlier devices. 12 recalls are linked to its devices.
FDA’s records also spell it “Ivoclar Vivadent, AG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ivoclar Vivadent, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
6in 2024
Class I Class II/III not classified
Planning a device like Ivoclar Vivadent, Inc.’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 “Ivoclar”
FDA records each applicant name separately; these may or may not be the same firm.