Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GC America, Inc. — Predicate Candidate Screening

128 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

79 daysmedian FDA review time

240 days90th percentile

128clearances measured

K-number	Device	Applicant	Decided	Review days
K253317	Cytrans™ Elashield	GC America, Inc.	2026-07-06	279
K261246	SRGC-06	GC America, Inc.	2026-06-18	63
K254109	G-CEM UNIVERSAL	GC America, Inc.	2026-05-18	150
K251124	G-Bond Universal	GC America, Inc.	2025-10-02	174
K250953	EQUIA LC ONE	GC America, Inc.	2025-09-19	175
K251946	G aenial Universal Injectable II	GC America, Inc.	2025-08-29	65
K200798	G-CEM ONE	GC America, Inc.	2020-11-24	243
K200682	BZF-29	GC America, Inc.	2020-10-02	200
K192597	Cytrans Granules	GC America, Inc.	2020-08-17	332
K193113	GC Temp Print	GC America, Inc.	2020-07-09	240
K193484	GC Fuji Triage EP	GC America, Inc.	2020-07-02	198
K192260	everX Flow	GC America, Inc.	2019-11-22	93
K182854	GC FujiCEM 2 (Improved)	GC America, Inc.	2019-07-11	274
K180917	GC Acrylic Primer	GC America, Inc.	2018-11-20	225
K181011	AIM2	GC America, Inc.	2018-07-12	86
K172382	GC Fuji Direct	GC America, Inc.	2018-04-02	237
K173500	NMF004A	GC America, Inc.	2018-03-08	115
K153130	Initial LiSi Block	GC America, Inc.	2016-09-13	319
K153325	Gradia Plus	GC America, Inc.	2016-07-12	236
K153231	G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Pr	GC America, Inc.	2016-07-06	240
K153136	Initial LiSi Press	GC America, Inc.	2016-06-30	244
K153127	everX Posterior	GC America, Inc.	2016-05-20	204
K152274	MSCB-001	GC America, Inc.	2016-03-25	226
K153253	GC Reline II	GC America, Inc.	2016-03-03	114
K151541	G-Fix	GC America, Inc.	2015-10-09	123
K143140	G-Premio BOND	GC America, Inc.	2015-04-20	168
K141562	MSN-006	GC America, Inc.	2014-09-05	85
K133182	HTFX-222	GC America, Inc.	2014-04-09	174
K133824	CERASMART	GC America, Inc.	2014-03-14	87
K133836	OPTIGLAZE COLOR	GC America, Inc.	2014-03-06	78
K123631	MFP-051	GC America, Inc.	2013-07-23	242
K113816	GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV	GC America, Inc.	2013-01-30	400
K120243	GAM-200	GC America, Inc.	2012-06-27	152
K120521	GC BLUE SILICONE	GC America, Inc.	2012-05-10	79
K103234	GC AADVA BO AC ABUTMENTS	GC America, Inc.	2011-06-30	240
K110871	FIT CHECKER ADVANCED	GC America, Inc.	2011-06-17	80
K101346	GC ORAL MOISTURIZING GEL	GC America, Inc.	2011-01-27	259
K102808	MI VARNISH	GC America, Inc.	2010-12-22	85
K093749	GC AADVA IMPLANT SYSTEM	GC America, Inc.	2010-12-06	364
K101420	GC FUJI TEMP	GC America, Inc.	2010-09-17	120
K092020	AADVA ZR COLORING LIQUID	GC America, Inc.	2009-09-29	85
K091388	GCUC-505	GC America, Inc.	2009-07-22	72
K091106	EQUIA	GC America, Inc.	2009-06-17	62
K090747	MI FLOW (GCUC-450)	GC America, Inc.	2009-06-10	82
K082740	GC AADVA ZR DISK	GC America, Inc.	2008-11-26	69
K082434	GDLS-200	GC America, Inc.	2008-11-14	81
K082171	GRADIA CORE	GC America, Inc.	2008-10-30	90
K082768	G-BOND PLUS	GC America, Inc.	2008-10-21	29
K080724	GC OPB-100	GC America, Inc.	2008-06-11	89
K080478	GRADIA FORTE	GC America, Inc.	2008-06-05	104

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda