Medical Device Manufacturer · KR , Incheon

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

18 submissions · 18 cleared · Since 2009

Recent clearances: EsCem RMGI, EsFlow PLUS, VioSeal

18

Total

18

Cleared

0

Denied

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

18 devices

1-12 of 18

Cleared Jul 02, 2026

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