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

Kuraray Co. — Predicate Candidate Screening

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

66 daysmedian FDA review time

114 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K990040	CLEARFIL SE BOND	Kuraray Co.	1999-02-04	29
K951813	CARIES DETECTOR	Kuraray Co.	1995-07-11	84
K933030	PANAVIA 21	Kuraray Co.	1994-02-24	247
K925383	PHOTO CLEARFIL OPAQUER	Kuraray Co.	1993-01-28	97
K925404	CLEARFIL PORCELAIN BOND ACTIVATOR	Kuraray Co.	1993-01-11	80
K912708	CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM	Kuraray Co.	1991-08-20	62
K912707	CLEARFIL LINER BOND SYSTEM	Kuraray Co.	1991-08-20	62
K910424	TEETHMATE-F	Kuraray Co.	1991-04-03	63
K900690	CLEARFIL VENEER BOND KIT	Kuraray Co.	1990-04-13	59
K897027	TEETHMATE-A	Kuraray Co.	1990-03-14	86
K890123	CLEARFIL CR INLAY	Kuraray Co.	1989-03-31	79
K882006	CLEARFIL PHOTO CORE	Kuraray Co.	1988-06-13	31
K872588	CLEARFIL PHOTO POSTERIOR	Kuraray Co.	1988-03-02	245
K872959	CLEARFIL PHOTO BOND	Kuraray Co.	1987-11-20	114
K873886	CLEARFIL PORCELAIN REPAIR SYSTEM	Kuraray Co.	1987-11-12	50
K872960	CLEARFIL POSTERIOR NEW BOND	Kuraray Co.	1987-08-11	13
K871637	CLEARFIL CORE NEW BOND	Kuraray Co.	1987-07-17	81
K871634	CLEARFIL FII NEW BOND	Kuraray Co.	1987-07-17	81
K871635	CLEARFIL POSTERIOR 3	Kuraray Co.	1987-07-16	80
K871636	CLEARFIL PORCELAIN BOND	Kuraray Co.	1987-07-02	66
K862942	PHOTO CLEARFIL BRIGHT	Kuraray Co.	1986-09-05	31
K862232	PANAVIA TC, AND PANAVIA OPAQUE	Kuraray Co.	1986-07-29	48
K860708	PHOTO CLEARFIL OPAQUER	Kuraray Co.	1986-04-17	50
K855211	PANAVIA EX, A DENTAL ADHESIVE	Kuraray Co.	1986-03-13	73
K850824	PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST	Kuraray Co.	1985-04-08	39

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