Dentis Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
37
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253493Dentis SQ-SL AXEL FixtureMarch 4, 2026
K241065ChecQ (AC100)March 21, 2025
K233921Luvis Chair (LC700C)September 6, 2024
K241063s-Clean ScanHealing AbutmentJuly 25, 2024
K240511Dentis s-Clean SQ-SL FixtureMay 20, 2024
K233544MESHEETFebruary 22, 2024
K230126Dentis s-Clean Regular AbutmentAugust 4, 2023
K230307Dentis i-Clean SystemJuly 11, 2023
K230246Dentis s-Clean SQ-SL Narrow Implant SystemMay 25, 2023
K230523s-Clean Link Abutment NarrowMay 24, 2023
K230203Dentis I-FIX AbutmentMay 3, 2023
K222367SAVE GBRMarch 23, 2023
K222451SAVE GBRFebruary 7, 2023
K222913s-Clean Link AbutmentJanuary 13, 2023
K222976MU SystemJanuary 12, 2023
K220440Dentis s-Clean Abutment MiniJune 16, 2022
K210410s-Clean Pre-Milled Abutment MiniSeptember 10, 2021
K210362s-Clean Pre-Milled AbutmentAugust 19, 2021
K210080Dentis s-Clean s-Line MiniJune 4, 2021
K210134Dentis s-Clean s-LineApril 19, 2021