FDA applicant
Factor, Ii, Inc.
FDA records 3 decisions for Factor, Ii, Inc. (Lakeside, AZ) from 1983 to 2000: 3 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and DZE (Implant, Endosseous, Root-Form). 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 Factor, Ii, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Factor, Ii, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Factor, Ii, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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