FDA.report

510(k) K250566

Device
EsCem RMGI
Applicant
Spident Co., Ltd.
510(k) number
K250566
Product code
EMA
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-20
Date received
2025-02-26
Regulation
872.3275
Classification name
Cement, Dental
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Hyemin Kwon
Address
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu Incheon KR 405-821 405-821

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EMA

510(k)DeviceApplicantDecision date
K253337REGEN Bioactive CementInter-Med, Inc.2026-04-15
K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH2026-03-20
K254063iCEM Universal PlusKulzer, LLC2025-12-19
K252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao Huge Biomaterials Company, Ltd.2025-12-12
K252808GlasIonomer FX-LCShofu Dental Corporation2025-12-09
K252165ZIRCONOMER PShofu Dental Corporation2025-10-28
K250953EQUIA LC ONEGC America, Inc.2025-09-19
K251775RODIN CementBelport Company, Inc., Gingi-Pak2025-09-02
K251470ResiCem EXShofu Dental Corporation2025-07-11
K250156Choice 2 DCBisco, Inc.2025-07-11
K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-AbutmentOverfibers S.R.L.2025-01-10
K240714Insure® Universal; Insure® Universal AutomixCosmedent, Inc.2024-07-24
K241204TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd.2024-06-28
K240888Calibra Abutment Resin CementDentsply Sirona2024-04-02
K233161BeautiLink SAShofu Dental Corporation2023-09-28