Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Tokuyama America, Inc. · Predicate Candidate Screening

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

82 daysmedian FDA review time

153 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days
K022641	TOKUYAMA REBASE II	Tokuyama America, Inc.	2002-10-02	55
K011854	TOKUYAMA M-BOND	Tokuyama America, Inc.	2001-09-04	83
K011685	BISTITE II DC	Tokuyama America, Inc.	2001-07-31	61
K010267	PALFIQUE ESTELITE LV CLEAR	Tokuyama America, Inc.	2001-02-27	29
K002863	PALFIQUE ESTELITE LV	Tokuyama America, Inc.	2001-01-04	113
K993917	TOKUYAMA ONE-UP-BOND F	Tokuyama America, Inc.	2000-02-02	77
K991711	BISTITE II SC	Tokuyama America, Inc.	1999-07-07	49
K982537	TOKUYAMA SOFRELINER	Tokuyama America, Inc.	1998-08-24	34
K980054	PALFIQUE ESTELITE	Tokuyama America, Inc.	1998-04-27	111
K980058	TOKUSO MAC BOND II	Tokuyama America, Inc.	1998-04-27	111
K980051	PALFIQUE ESTELITE PASTE	Tokuyama America, Inc.	1998-02-24	49
K973245	TOKUSO REBASE MR. BOND	Tokuyama America, Inc.	1997-10-07	39
K953589	TOKUYAMA SOFT RELINING	Tokuyama America, Inc.	1996-01-18	170
K913099	PALFIQUE LITEPOSTERIOR	Tokuyama America, Inc.	1991-10-02	82
K913100	PALFIQUE INLAY	Tokuyama America, Inc.	1991-10-02	82
K911524	PALFIQUE ESTELITE	Tokuyama America, Inc.	1991-05-29	54
K911525	TOKUSO LIGHT BOND	Tokuyama America, Inc.	1991-05-15	40
K896980	PALFIQUE LIGHT LINER	Tokuyama America, Inc.	1990-05-15	153
K896981	TOKUSO REBASE	Tokuyama America, Inc.	1990-05-15	153
K897009	PALFIQUE LIGHT BONDING AGENT	Tokuyama America, Inc.	1990-05-15	153
K897010	PALFIQUE LIGHT COMPOSITE RESIN	Tokuyama America, Inc.	1990-05-15	153
K897011	PALFIQUE LIGHT-S COMPOSITE RESIN	Tokuyama America, Inc.	1990-05-15	153

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