FDA applicant
Datum Dental, Ltd.
FDA records 4 decisions for Datum Dental, Ltd. (Lod, IL) from 2016 to 2022: 4 510(k) clearances. Most are in product codes NPL (Barrier, Animal Source, Intraoral) and NPM (Bone Grafting Material, Animal Source). Since 2016 its 510(k)s took a median of 219 days from receipt to decision, against 188 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 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 Datum Dental, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Datum Dental, Ltd.’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