FDA applicant
Ortho Source
FDA records 9 decisions for Ortho Source (North Hollywood, CA) from 1986 to 1992: 9 510(k) clearances. Most are in product codes DYH (Adhesive, Bracket And Tooth Conditioner, Resin) and EBC (Sealant, Pit And Fissure, And Conditioner). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ortho Source’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ortho Source since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ortho Source’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 “Ortho”
FDA records each applicant name separately; these may or may not be the same firm.