FDA applicant
Sybron Dental Specialties, Inc.
FDA records 121 decisions for Sybron Dental Specialties, Inc. (Orange, CA) from 1994 to 2018: 121 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EMA (Cement, Dental). Since 2016 its 510(k)s took a median of 206 days from receipt to decision, against 212 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 8 of them its own earlier devices. 20 recalls are linked to its devices.
FDA’s records also spell it “Sybron Dental Specialties”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sybron Dental Specialties, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Sybron Dental Specialties, 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 “Sybron”
FDA records each applicant name separately; these may or may not be the same firm.