FDA applicant
Dentium Co., Ltd.
FDA records 23 decisions for Dentium Co., Ltd. (Yongin-Si, KR) from 2004 to 2022: 23 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 176 days from receipt to decision, against 202 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 20 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Dentium, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dentium Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2007
Class I Class II/III not classified
Planning a device like Dentium Co., 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) ReportOther applicant names beginning “Dentium”
FDA records each applicant name separately; these may or may not be the same firm.