FDA applicant
Dentium Co., Ltd (Ict Branch)
FDA records 4 decisions for Dentium Co., Ltd (Ict Branch) (Suwon-Si, KR) from 2020 to 2023: 4 510(k) clearances. Most are in product codes OAS (X-Ray, Tomography, Computed, Dental) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 335 days from receipt to decision, against 85 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 Dentium Co., Ltd (Ict Branch)’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Dentium Co., Ltd (Ict Branch)’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 “Dentium”
FDA records each applicant name separately; these may or may not be the same firm.