FDA applicant
Dentalez Group
FDA records 13 decisions for Dentalez Group (Lancaster, PA) from 1988 to 2003: 13 510(k) clearances. Most are in product codes EFA (Handpiece, Belt And/Or Gear Driven, Dental) and EIA (Unit, Operative Dental). Its devices cite 3 predicates, 2 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dentalez Group’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Dentalez Group since 2007.
Recalls per year
2in 2024
Class I Class II/III not classified
Planning a device like Dentalez Group’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 “Dentalez”
FDA records each applicant name separately; these may or may not be the same firm.