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

Foremost Dental Mfg., Inc. — Predicate Candidate Screening

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

81 daysmedian FDA review time

136 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K982201	ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)	Foremost Dental Mfg., Inc.	1998-08-10	49
K981813	PERMACEM AUTOMIX LUTING CEMENT SYSTEM	Foremost Dental Mfg., Inc.	1998-07-10	49
K980963	HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM	Foremost Dental Mfg., Inc.	1998-05-11	56
K970683	ZENTIH FLOWABLE COMPOSITE (MULTIPLE)	Foremost Dental Mfg., Inc.	1997-07-15	141
K970775	TEMPO CEM (MULTIPLE)	Foremost Dental Mfg., Inc.	1997-06-03	91
K970774	TEMPOCEM NE (MULTIPLE)	Foremost Dental Mfg., Inc.	1997-06-03	91
K954867	IONOSIT SEAL	Foremost Dental Mfg., Inc.	1996-03-08	136
K935032	ZENITH TOTAL ETCH 10% PHOSPHORIC ACID	Foremost Dental Mfg., Inc.	1994-01-18	90
K890464	ZENITH 40% PHOSPHORIC ACID GEL	Foremost Dental Mfg., Inc.	1989-02-13	14
K871562	IONOCAL	Foremost Dental Mfg., Inc.	1987-05-20	28
K864898	FOREMOST DENTIN ADHESIVE	Foremost Dental Mfg., Inc.	1987-02-12	59
K853055	LIGHT CURE FILLING MATERIAL	Foremost Dental Mfg., Inc.	1985-11-19	123
K845033	FOREMOST DENTIN ADHESIVE	Foremost Dental Mfg., Inc.	1985-03-18	81
K845034	FOREMOST LITE CURE PIT & FISSURE SEALANT	Foremost Dental Mfg., Inc.	1985-03-18	81

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