GC America, Inc.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21

Categories8

Latest Approval2025-10-02

Type	Number	Device Name	Code	Date
510(k)	K251124	G-Bond Universal	KLE	2025-10-02	View
510(k)	K250953	EQUIA LC ONE	EMA	2025-09-19	View
510(k)	K251946	G aenial Universal Injectable II	EBF	2025-08-29	View
510(k)	K200798	G-CEM ONE	EMA	2020-11-24	View
510(k)	K200682	BZF-29	KLE	2020-10-02	View
510(k)	K192597	Cytrans Granules	LYC	2020-08-17	View
510(k)	K193113	GC Temp Print	EBG	2020-07-09	View
510(k)	K193484	GC Fuji Triage EP	EMA	2020-07-02	View
510(k)	K192260	everX Flow	EBF	2019-11-22	View
510(k)	K182854	GC FujiCEM 2 (Improved)	EMA	2019-07-11	View
510(k)	K180917	GC Acrylic Primer	KLE	2018-11-20	View
510(k)	K181011	AIM2	ELW	2018-07-12	View
510(k)	K172382	GC Fuji Direct	EMA	2018-04-02	View
510(k)	K173500	NMF004A	EBF	2018-03-08	View
510(k)	K153130	Initial LiSi Block	EIH	2016-09-13	View
510(k)	K153325	Gradia Plus	EBF	2016-07-12	View
510(k)	K153231	G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer	EMA	2016-07-06	View
510(k)	K153136	Initial LiSi Press	EIH	2016-06-30	View
510(k)	K153127	everX Posterior	EBF	2016-05-20	View
510(k)	K152274	MSCB-001	EIH	2016-03-25	View
510(k)	K153253	GC Reline II	EBI	2016-03-03	View