FDA applicant
O Co., Inc.
FDA records 17 decisions for O Co., Inc. (Albuquerque, NM) from 1989 to 2003: 17 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 8 predicates, 2 of them its own earlier devices. 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 O Co., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for O Co., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like O Co., 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