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

Noritake Co., Inc. — Predicate Candidate Screening

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

79 daysmedian FDA review time

91 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K111383	ZIRPRIME	Noritake Co., Inc.	2011-08-12	87
K111107	SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE	Noritake Co., Inc.	2011-06-30	71
K052304	SUPER PORCELAIN EX-3 PRESS	Noritake Co., Inc.	2005-11-23	91
K050920	CZR PRESS LF STAINS	Noritake Co., Inc.	2005-05-11	29
K050160	KATANA ZIRCONIA	Noritake Co., Inc.	2005-02-07	13
K043462	CZR PRESS LF	Noritake Co., Inc.	2005-01-11	27
K031968	CERABIEN ZR	Noritake Co., Inc.	2003-12-22	179
K033049	CZR PRESS	Noritake Co., Inc.	2003-10-24	25
K992023	GRAND CERAM	Noritake Co., Inc.	1999-09-03	79
K992024	SUPER PORCELAIN TI-22	Noritake Co., Inc.	1999-08-27	72
K983470	SUPER PORCELAIN STAIN- PURE WHITE	Noritake Co., Inc.	1998-12-22	82
K983247	SUPER PORCELAIN ADDMATE	Noritake Co., Inc.	1998-11-03	48
K982766	PASTE OPAQUE EX-3	Noritake Co., Inc.	1998-10-30	85
K884356	NORITAKE SUPER PORCELAIN EX-3	Noritake Co., Inc.	1989-01-10	85

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