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

Kuraray Medical, Inc. · Predicate Candidate Screening

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

40 daysmedian FDA review time

86 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days
K120379	PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE)	Kuraray Medical, Inc.	2012-03-30	52
K120378	PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE)	Kuraray Medical, Inc.	2012-03-30	52
K111975	CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTR	Kuraray Medical, Inc.	2011-10-14	94
K100328	CLEARFIL MAJETY POSTERIOR	Kuraray Medical, Inc.	2010-03-05	29
K092281	CLEARFIL MAJESTY POSTERIOR PLT	Kuraray Medical, Inc.	2009-10-27	90
K081583	CLEARFIL SA CEMENT	Kuraray Medical, Inc.	2008-07-28	53
K071169	CLEARFIL MAJESTY POSTERIOR PLT	Kuraray Medical, Inc.	2007-06-20	54
K070325	CLEARFIL MAJESTY ESTHETIC PLT	Kuraray Medical, Inc.	2007-03-21	44
K062409	K-ETCHANT GEL	Kuraray Medical, Inc.	2006-11-08	83
K061906	CLEARFIL CERAMIC PRIMER	Kuraray Medical, Inc.	2006-09-28	85
K062382	CLEARFIL DC BOND	Kuraray Medical, Inc.	2006-09-27	43
K062410	CLEARFIL ESTHETIC CEMENT & DC BOND	Kuraray Medical, Inc.	2006-09-26	40
K061860	CLEARFIL MAJESTY ESTHETIC	Kuraray Medical, Inc.	2006-09-18	80
K043177	CLEAFIL DC CORE AUTOMIX	Kuraray Medical, Inc.	2004-12-17	31
K042913	CLEARFIL TRI-S BOND	Kuraray Medical, Inc.	2004-11-26	36
K033970	CLEARFIL PHOTO CORE PLT	Kuraray Medical, Inc.	2004-03-26	95
K033938	CLEARFIL PROTECT BOND	Kuraray Medical, Inc.	2004-01-29	41
K033267	EPRICORD	Kuraray Medical, Inc.	2003-12-22	74
K032455	PANAVIA F 2.0	Kuraray Medical, Inc.	2003-11-07	88
K024356	CLEARFIL SILANE KIT	Kuraray Medical, Inc.	2003-03-26	86
K023842	CLEARFIL SE BOND PLUS	Kuraray Medical, Inc.	2003-02-11	85
K023002	CLEARFIL AP-X PLT	Kuraray Medical, Inc.	2002-10-25	46
K022999	CLEARFIL AP-X PLT INTRO KIT	Kuraray Medical, Inc.	2002-10-24	45
K021427	CLEARFIL SA PRIMER	Kuraray Medical, Inc.	2002-06-07	35
K012737	CHROMA ZONE COLOR STAIN	Kuraray Medical, Inc.	2001-09-14	31
K012735	CLEARFIL DC CEMENT	Kuraray Medical, Inc.	2001-09-14	31
K012740	CLEARFIL AP-X	Kuraray Medical, Inc.	2001-09-14	31
K012742	TEETHMATE F-1	Kuraray Medical, Inc.	2001-09-14	31
K012733	CARIES DETECTOR	Kuraray Medical, Inc.	2001-09-14	31
K012734	CLEARFIL NEW BOND	Kuraray Medical, Inc.	2001-09-14	31
K012730	CLEARFIL PORCELAIN BOND ACTIVATOR	Kuraray Medical, Inc.	2001-09-13	30
K012729	CLEARFIL REPAIR	Kuraray Medical, Inc.	2001-09-13	30
K012707	ESTENIA	Kuraray Medical, Inc.	2001-09-13	30
K012705	CLEARFIL PHOTO CORE	Kuraray Medical, Inc.	2001-09-11	28
K012704	CLEARFIL ST OPAQUER	Kuraray Medical, Inc.	2001-09-10	27
K012703	CLEARFIL CORE NEW BOND	Kuraray Medical, Inc.	2001-09-10	27
K012442	MODIFICATION TO CLEARFIL SE BOND	Kuraray Medical, Inc.	2001-09-10	41
K012441	PANAVIA F	Kuraray Medical, Inc.	2001-09-06	37
K012438	MODIFICATION TO PANAVIA 21	Kuraray Medical, Inc.	2001-09-05	36
K012440	MODIFICATION TO CLEARFIL LINER BOND 2V	Kuraray Medical, Inc.	2001-09-05	36
K012432	MODIFICATION TO CLEARFIL PHOTO BOND	Kuraray Medical, Inc.	2001-09-04	35
K012436	MODIFICATION TO ALLOY PRIMER	Kuraray Medical, Inc.	2001-09-04	35

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