FDA applicant
Pac-Dent, Inc.
FDA records 8 decisions for Pac-Dent, Inc. (Brea, CA) from 2020 to 2022: 8 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and FXX (Mask, Surgical). Since 2016 its 510(k)s took a median of 184 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. 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 Pac-Dent, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Pac-Dent, 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) Report