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510(k) K091106

Device
EQUIA
Applicant
GC AMERICA, INC.
510(k) number
K091106
Product code
EMA  
Decision
Substantially Equivalent (SESE)
Decision date
2009-06-17
Date received
2009-04-16
Regulation
872.3275
Classification name
Cement, Dental
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARK HEISS
Address
3737 W. 127th St. Alsip IL US 60803 60803

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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

Legacy Summary#

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FDA Review#

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