FDA applicant
Shofu Dental Corp.
FDA records 97 decisions for Shofu Dental Corp. (San Marcos, CA) from 1981 to 2025: 97 510(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 110 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Shofu Dental Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shofu Dental Corp.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Shofu Dental 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