Not currently registered with FDA under this name
Foremost Dental Mfg., Inc.
Englewood, NJ, United States. Named as applicant on 15 dental 510(k) clearances between 1985 and 1998. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 151985–1998
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1980–2026
510(k) clearances
Clearances on which FDA names Foremost Dental Mfg., Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Aug 1998 | K982201 | ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) | EBF Resin Tooth Shade Material |
| 10 Jul 1998 | K981813 | PERMACEM AUTOMIX LUTING CEMENT SYSTEM | EBF Resin Tooth Shade Material |
| 11 May 1998 | K980963 | HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES) | ELW Impression Material |
| 15 Jul 1997 | K970683 | ZENTIH FLOWABLE COMPOSITE (MULTIPLE) | EBF Resin Tooth Shade Material |
| 3 Jun 1997 | K970775 | TEMPO CEM (MULTIPLE) | EMA Dental Cement |
| 3 Jun 1997 | K970774 | TEMPOCEM NE (MULTIPLE) | EMA Dental Cement |
| 8 Mar 1996 | K954867 | IONOSIT SEAL | EBC Pit and Fissure Sealant and Conditioner |
| 21 Jan 1994 | K935689 | IONOSIT BASE LINER | EBD Resin Filling Material Coating |
| 18 Jan 1994 | K935032 | ZENITH TOTAL ETCH 10% PHOSPHORIC ACID | EBF Resin Tooth Shade Material |
| 13 Feb 1989 | K890464 | ZENITH 40% PHOSPHORIC ACID GEL | EBC Pit and Fissure Sealant and Conditioner |
| 20 May 1987 | K871562 | IONOCAL | EMA Dental Cement |
| 12 Feb 1987 | K864898 | FOREMOST DENTIN ADHESIVE | EMA Dental Cement |
| 19 Nov 1985 | K853055 | LIGHT CURE FILLING MATERIAL | EBF Resin Tooth Shade Material |
| 18 Mar 1985 | K845034 | FOREMOST LITE CURE PIT & FISSURE SEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 18 Mar 1985 | K845033 | FOREMOST DENTIN ADHESIVE | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: indigodental GmbH (3), DMG Chemisch-Pharmazeutische Fabrik GmbH (3), Sterngold (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.