FDA applicant
Arum Dentistry Co., Ltd.
FDA records 17 decisions for Arum Dentistry Co., Ltd. (Daejeon, KR) from 2020 to 2025: 17 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 129 days from receipt to decision, against 158 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 13 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 Arum Dentistry Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Arum Dentistry Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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