Medical Device Manufacturer · KR , Incheon

Spident Co., Ltd. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2009

Recent clearances: EsCem RMGI, EsFlow PLUS, VioSeal

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spident Co., Ltd. Dental ✕

17 devices

1-12 of 17

Cleared Jun 20, 2025

Cleared May 30, 2025

Cleared Nov 07, 2024

Cleared Nov 01, 2024

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37...

Cleared Jul 22, 2024

K-Bond Universal

Cleared Jul 24, 2023

Cleared Dec 19, 2022

Cleared Mar 10, 2022

Cleared Sep 30, 2016

Cleared Jun 11, 2014

Cleared Jun 10, 2014

ESTEMP IMPLANT, ESTEMP CLEAR

Cleared May 24, 2012