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

DiaDent Group International has 24 FDA 510(k) cleared dental devices. Based in Chungcheong Buk-Do, KR.

Latest FDA clearance: Sep 2026. Active since 2013.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Underwriters Laboratories, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - DiaDent Group International

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
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