FDA.reportPublic FDA data

510(k) K213609

Device
NOVA RESIN dual cure, self adhesive resin cement
Applicant
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
510(k) number
K213609
Product code
EMA
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-09
Date received
2021-11-15
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
No

Applicant Contact#

Contact
Hüsamettin Sonmez
Address
Fetih Mahallesi Mahir Sokak No:5/201 Karatay Konya TR 42030 42030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EMA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254109G-CEM UNIVERSALGC America, Inc.2026-05-18
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
K250566EsCem RMGISpident Co., Ltd.2025-06-20
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