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

Shofu Dental Corp. — Predicate Candidate Screening

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

63 daysmedian FDA review time

141 days90th percentile

59clearances measured

K-number	Device	Applicant	Decided	Review days
K111855	HY-BOND RESIGLASS	Shofu Dental Corp.	2011-11-17	141
K110235	BEAUTIBOND MULTI	Shofu Dental Corp.	2011-05-13	107
K110252	BEAUTIBOND MULTI PR PLUS	Shofu Dental Corp.	2011-05-13	105
K101603	BEAUTIFIL FLOW PLUS	Shofu Dental Corp.	2010-08-23	76
K101621	LITE ART	Shofu Dental Corp.	2010-08-23	75
K093559	VINTAGE MP	Shofu Dental Corp.	2010-03-03	105
K082744	BEAUTIBOND	Shofu Dental Corp.	2008-12-11	84
K080517	RESICEM	Shofu Dental Corp.	2008-06-11	107
K080834	VINTAGE ART	Shofu Dental Corp.	2008-06-11	78
K080068	BEAUTIFIL OPAQUER	Shofu Dental Corp.	2008-02-28	49
K071742	BEAUTIFIL II	Shofu Dental Corp.	2007-08-15	49
K071452	FL BOND II	Shofu Dental Corp.	2007-07-09	45
K052033	VINTAGE ZR	Shofu Dental Corp.	2005-11-18	114
K051818	BEAUTIFIL FLOW	Shofu Dental Corp.	2005-08-03	29
K050401	CERAMAGE	Shofu Dental Corp.	2005-04-28	70
K040079	M.L. PRIMER	Shofu Dental Corp.	2004-09-09	238
K032416	VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN	Shofu Dental Corp.	2004-02-05	184
K032165	VINTAGE AL	Shofu Dental Corp.	2003-09-16	63
K031467	GLASIONOMER FX-II	Shofu Dental Corp.	2003-07-17	70
K021613	NIVEOUS LIQUID DAM	Shofu Dental Corp.	2002-06-20	35
K010914	BEAUTIFIL	Shofu Dental Corp.	2001-04-20	24
K002461	HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT	Shofu Dental Corp.	2000-09-26	47
K982461	GLASIONOMER CEMENT CX PLUS	Shofu Dental Corp.	1998-08-24	40
K972292	SOLIDEX	Shofu Dental Corp.	1997-10-29	132
K973247	VINTAGE HALO	Shofu Dental Corp.	1997-10-16	48
K971927	HI DENSE TC	Shofu Dental Corp.	1997-06-30	34
K953612	IMPERVA FLUOROBOND	Shofu Dental Corp.	1995-10-04	63
K953613	IMPERVA ENSURABOND	Shofu Dental Corp.	1995-10-04	63
K945451	HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE	Shofu Dental Corp.	1995-02-27	112
K940122	HY BOND, GLASIONOMER CX	Shofu Dental Corp.	1994-05-02	112
K920893	LITE FILL II P	Shofu Dental Corp.	1992-09-01	188
K920892	LITE FIL II A	Shofu Dental Corp.	1992-09-01	188
K913946	IMPERVA DUAL	Shofu Dental Corp.	1991-12-03	90
K913947	IMPERVA BOND	Shofu Dental Corp.	1991-10-09	35
K896071	ULTRA II PORCELAIN POLISHING PASTE	Shofu Dental Corp.	1990-08-14	299
K893481	CRYSTAR(TM) ANTI-GREENING LIQUID	Shofu Dental Corp.	1989-07-14	71
K884214	CRYSTAR(TM) VINTAGE PORCELAIN	Shofu Dental Corp.	1988-12-08	63
K871899	IMPERVA-A	Shofu Dental Corp.	1987-07-21	67
K871898	IMPERVA-P	Shofu Dental Corp.	1987-07-21	67
K863141	KULZER GLASS IONOMER LINER	Shofu Dental Corp.	1986-08-26	11
K862280	SHOFU LINING CEMENT	Shofu Dental Corp.	1986-06-23	7
K861005	GLASIONOMER BASE CEMENT	Shofu Dental Corp.	1986-04-25	38
K854347	HYBRID POINTS	Shofu Dental Corp.	1985-12-27	59
K850913	GLAS IONOMER CEMENT	Shofu Dental Corp.	1985-04-10	36
K843901	ISOSTATIC CONDENSER	Shofu Dental Corp.	1984-12-03	61
K841195	GLAS IONOMER CEMENT	Shofu Dental Corp.	1984-05-14	54
K841196	HY-BOND ZINC OXIDE EUGENOL TEMP.	Shofu Dental Corp.	1984-05-11	51
K840873	CRYSTAR PORCELAIN MARGIN POWDER/LIQUID	Shofu Dental Corp.	1984-04-25	58
K834497	SHOFU PORCELAIN STAIN	Shofu Dental Corp.	1984-03-06	77
K833643	CRYSTAR PORCELAIN	Shofu Dental Corp.	1983-12-29	73

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