FDA applicant
Dental Choice Holdings, LLC
FDA records 2 decisions for Dental Choice Holdings, LLC (Louisville, KY) from 2019 to 2022: 2 510(k) clearances. Most are in product codes OBR (Mouthguard, Over-The-Counter) and LRK (Device, Anti-Snoring). Its devices cite 1 predicate, 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 Dental Choice Holdings, LLC’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 2019.
Planning a device like Dental Choice Holdings, 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) Report