FDA applicant
Dentalmax Co., Ltd.
FDA records 3 decisions for Dentalmax Co., Ltd. (Cheonan-Si, KR) from 2018 to 2024: 3 510(k) clearances. All are in product code EIH (Powder, Porcelain). Since 2016 its 510(k)s took a median of 158 days from receipt to decision, against 131 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 Dentalmax Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Dentalmax 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) Report