FDA applicant
Implant Direct, LLC
FDA records 10 decisions for Implant Direct, LLC (Calabasas, CA) from 2006 to 2009: 10 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 17 predicates, 10 of them its own earlier devices. 18 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Implant Direct, LLC’s devices, and how often a recall has named them.
FDA decisions per year
3in 2009
2026 so far, outlined.
Recalls per year
4in 2019
Class I Class II/III not classified
Planning a device like Implant Direct, LLC’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) ReportOther applicant names beginning “Implant”
FDA records each applicant name separately; these may or may not be the same firm.