Foremost Dental Mfg., Inc.

Englewood, NJ, US

Foremost Dental Mfg., Inc. appears in FDA device records in Englewood, NJ. FDA records list 15 510(k) clearances between 1985-03-18 and 1998-08-10, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 15
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 15 510(k) clearances for Foremost Dental Mfg., Inc. between 1985 and 1998. The busiest year on record is 1985, with 3. The most recent is 1998, with 3.

Clearances by year, as a table

510(k) clearance decisions for Foremost Dental Mfg., Inc., by decision year
Year	Clearances
1985	3
1987	2
1989	1
1994	2
1996	1
1997	3
1998	3

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K982201	ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)	EBF	Substantially Equivalent	1998-08-10
K981813	PERMACEM AUTOMIX LUTING CEMENT SYSTEM	EBF	Substantially Equivalent	1998-07-10
K980963	HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)	ELW	Substantially Equivalent	1998-05-11
K970683	ZENTIH FLOWABLE COMPOSITE (MULTIPLE)	EBF	Substantially Equivalent	1997-07-15
K970775	TEMPO CEM (MULTIPLE)	EMA	Substantially Equivalent	1997-06-03
K970774	TEMPOCEM NE (MULTIPLE)	EMA	Substantially Equivalent	1997-06-03
K954867	IONOSIT SEAL	EBC	Substantially Equivalent	1996-03-08
K935689	IONOSIT BASE LINER	EBD	Substantially Equivalent	1994-01-21
K935032	ZENITH TOTAL ETCH 10% PHOSPHORIC ACID	EBF	Substantially Equivalent	1994-01-18
K890464	ZENITH 40% PHOSPHORIC ACID GEL	EBC	Substantially Equivalent	1989-02-13
K871562	IONOCAL	EMA	Substantially Equivalent	1987-05-20
K864898	FOREMOST DENTIN ADHESIVE	EMA	Substantially Equivalent	1987-02-12
K853055	LIGHT CURE FILLING MATERIAL	EBF	Substantially Equivalent	1985-11-19
K845034	FOREMOST LITE CURE PIT & FISSURE SEALANT	EBC	Substantially Equivalent	1985-03-18
K845033	FOREMOST DENTIN ADHESIVE	EBF	Substantially Equivalent	1985-03-18

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain