FDA applicant
BioHorizons Implant Systems, Inc.
FDA records 41 decisions for BioHorizons Implant Systems, Inc. (Birmingham, AL) from 1996 to 2026: 41 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 162 days from receipt to decision, against 201 for FDA’s reviews in the same codes and years. Its devices cite 118 predicates, 76 of them its own earlier devices. 11 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided BioHorizons Implant Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like BioHorizons 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