Arum Dentistry Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250280SD TL Implant SystemJuly 23, 2025
K250063ARENA Star, Galaxy StarJuly 10, 2025
K241703SD Implant SystemFebruary 24, 2025
K242753SD TL Implant SystemJanuary 6, 2025
K242245Customized AbutmentNovember 25, 2024
K232559C&B NFH HybridSeptember 11, 2024
K240603Ti-Base & Master FixJune 5, 2024
K234112Customized AbutmentMay 9, 2024
K240091NB Mini Implant SystemApril 26, 2024
K232560Angled AbutmentDecember 19, 2023
K230725NB Implant SystemJuly 1, 2023
K223634Customized AbutmentApril 28, 2023
K223253Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)February 27, 2023
K222131NB 1 SA Implant SystemSeptember 19, 2022
K213506NB 1 SA Implant SystemApril 6, 2022
K210817C&B 5.0 HybridDecember 8, 2021
K193425Pre-Milled BlankMarch 9, 2020