Medical Device Manufacturer · KR , Chungcheong Buk-Do

DiaDent Group International - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2013

Recent clearances: DIA-CEM, DIAFIL, DIAFIL Bulk FLOW (Economic Package)

22

Total

22

Cleared

0

Denied

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

22 devices

1-22 of 22

Cleared Jul 09, 2026

Cleared Jun 02, 2026

Cleared May 19, 2026

DIAFIL Bulk FLOW (Economic Package)

Cleared Mar 19, 2026

Cleared Jul 28, 2023

Cleared Jun 15, 2022

Dia-X Bond Universal

Cleared Jan 31, 2022

DIAPLUS Universal

Cleared Jun 28, 2021

Diafil & Diafil Capsule

Cleared Mar 25, 2021

Cleared Sep 18, 2020

DIA-ROOT BIO MTA

Cleared Aug 07, 2020

Cleared Jun 25, 2020

DIA-ROOT BIO Sealer

Cleared May 26, 2020

Cleared Mar 27, 2020

Cleared Mar 25, 2020

Cleared Mar 20, 2020

DIAFIL & DIAFIL Capsule

Cleared Feb 13, 2020

Cleared Feb 13, 2020

Cleared Feb 07, 2020

DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill...

Cleared Sep 26, 2019

Cleared Jun 03, 2019

Cleared Aug 16, 2013

Data Source

Sourced from the FDA 510(k) public files . 175,730 total devices indexed.

Last updated: Aug 06, 2026