Medical Device Manufacturer · KR , Chungcheong Buk-Do

DiaDent Group International - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 2013

Recent clearances: Dia-X Sil Heavy Body, Dia-X Sil Light Body, DIA-CEM

24
Total
24
Cleared
0
Denied

FDA 510(k) Regulatory Record - DiaDent Group International Dental ✕

24 devices
1-24 of 24
Cleared Sep 16, 2026
Dia-X Sil Heavy Body
K254142 · ELW
Dental · 268d
Cleared Sep 16, 2026
Dia-X Sil Light Body
K254152 · ELW
Dental · 268d
Cleared Jul 09, 2026
DIA-CEM
K261166 · EMA
Dental · 91d
Cleared Jun 02, 2026
DIAFIL
K261093 · EBF
Dental · 61d
Cleared May 19, 2026
DIAFIL Bulk FLOW (Economic Package)
K261071 · EBF
Dental · 48d
Cleared Mar 19, 2026
Dia-X Sil Bite
K254112 · ELW
Dental · 90d
Cleared Jul 28, 2023
Dia-Cem
K231552 · EMA
Dental · 59d
Cleared Jun 15, 2022
Dia-X Bond Universal
K220804 · KLE
Dental · 89d
Cleared Jan 31, 2022
DIAPLUS Universal
K213401 · KLE
Dental · 105d
Cleared Jun 28, 2021
Diafil & Diafil Capsule
K210421 · EBF
Dental · 137d
Cleared Mar 25, 2021
DiaPaste
K210333 · KIF
Dental · 48d
Cleared Sep 18, 2020
DIA-ROOT BIO MTA
K200174 · KIF
Dental · 239d
Cleared Aug 07, 2020
D-LUX+
K200809 · EBZ
Dental · 133d
Cleared Jun 25, 2020
DIA-ROOT BIO Sealer
K200175 · KIF
Dental · 154d
Cleared May 26, 2020
DiaPlus
K192392 · KLE
Dental · 266d
Cleared Mar 27, 2020
Diapaste
K190091 · KIF
Dental · 434d
Cleared Mar 25, 2020
DiaFil Flow
K192284 · EBF
Dental · 216d
Cleared Mar 20, 2020
DIAFIL & DIAFIL Capsule
K192510 · EBF
Dental · 190d
Cleared Feb 13, 2020
DiaTemp Flow
K192022 · EBG
Dental · 199d
Cleared Feb 13, 2020
DiaTemp
K192158 · EBG
Dental · 188d
Cleared Feb 07, 2020
DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill...
K192273 · KLE
Dental · 169d
Cleared Sep 26, 2019
Dia-Proseal
K182009 · KIF
Dental · 426d
Cleared Jun 03, 2019
Diapex Plus
K182625 · KIF
Dental · 252d
Cleared Aug 16, 2013
D-LUX
K130163 · EBZ
Dental · 205d
Filters
All24 Dental 24