FDA applicant
Led Dental, Inc.
FDA records 3 decisions for Led Dental, Inc. (White Rock, British Columbia, CA) from 2007 to 2016: 3 510(k) clearances. Most are in product codes NXV (Diagnostic Light, Soft Tissue Detector) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Its devices cite 3 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 Led Dental, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Led Dental, 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