Foremost Dental Mfg., Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Foremost Dental Mfg., Inc.” (first 1985, latest 1998), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 81 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 6 | 6 |
| EMA | Cement, Dental | 4 | 4 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 3 | 3 |
| EBD | Coating, Filling Material, Resin | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
Review panels
- Dental (15)
Most recent Foremost Dental Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982201 | ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) | EBF | 1998-08-10 | 49 |
| K981813 | PERMACEM AUTOMIX LUTING CEMENT SYSTEM | EBF | 1998-07-10 | 49 |
| K980963 | HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES) | ELW | 1998-05-11 | 56 |
| K970683 | ZENTIH FLOWABLE COMPOSITE (MULTIPLE) | EBF | 1997-07-15 | 141 |
| K970775 | TEMPO CEM (MULTIPLE) | EMA | 1997-06-03 | 91 |
| K970774 | TEMPOCEM NE (MULTIPLE) | EMA | 1997-06-03 | 91 |
| K954867 | IONOSIT SEAL | EBC | 1996-03-08 | 136 |
| K935689 | IONOSIT BASE LINER | EBD | 1994-01-21 | 53 |
| K935032 | ZENITH TOTAL ETCH 10% PHOSPHORIC ACID | EBF | 1994-01-18 | 90 |
| K890464 | ZENITH 40% PHOSPHORIC ACID GEL | EBC | 1989-02-13 | 14 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Foremost Dental Mfg., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Foremost Dental, LLC (1 510(k)s)
- Foremost Mfg., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Foremost Dental Mfg., Inc.?
FDA lists 15 510(k) clearances under the applicant name “Foremost Dental Mfg., Inc.” (first 1985, latest 1998), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Foremost Dental Mfg., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Foremost Dental Mfg., Inc. is 81 days.
Which FDA product codes appear under Foremost Dental Mfg., Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 6); EMA (Cement, Dental, 4); EBC (Sealant, Pit And Fissure, And Conditioner, 3).
Next steps
- See all 15 Foremost Dental Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Foremost Dental Mfg., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.