FDA applicant
Universal Implant Systems, Inc.
FDA records 2 decisions for Universal Implant Systems, Inc. (Washington, DC) from 1991 to 2001: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 9 predicates, 0 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 Universal Implant Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Universal Implant Systems, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Universal Implant Systems, 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