FDA applicant
Ormco Corp.
FDA records 46 decisions for Ormco Corp. (Glendora, CA) from 1978 to 2025: 46 510(k) clearances. Most are in product codes DYH (Adhesive, Bracket And Tooth Conditioner, Resin) and DYW (Bracket, Plastic, Orthodontic). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 6 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Ormco Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ormco Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2007
Class I Class II/III not classified
Planning a device like Ormco Corp.’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) Report