Espe-Premier Sales Co.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Espe-Premier Sales Co.” (first 1981, latest 1981), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 3 | 3 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (10)
Most recent Espe-Premier Sales Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K812119 | NIMETIC-DISPERS | EBF | 1981-08-31 | 35 |
| K812118 | NIMETIC POLISHING PASTE | EJR | 1981-08-31 | 35 |
| K812117 | PERMAGUM ADHESIVE | KLE | 1981-08-31 | 35 |
| K812116 | PERMAGUM | KLE | 1981-08-31 | 35 |
| K812115 | KETAC-CHEM | EMA | 1981-08-31 | 35 |
| K811624 | VISIO-SEAL | EBC | 1981-06-26 | 17 |
| K810266 | ETCHING GEL | EJK | 1981-02-23 | 21 |
| K810265 | VISIO-BAND | KLE | 1981-02-23 | 21 |
| K803227 | VISIO-DISPERS | EBF | 1981-01-14 | 26 |
| K803209 | ELIPAR LIGHT SOURCE | EBZ | 1981-01-14 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Espe-Premier Sales Co..
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.
- Espe GmbH (Us) (59 510(k)s)
- Espe Dental AG (29 510(k)s)
- Espe GmbH & Co. Kg. (17 510(k)s)
- Espe Dental Products (8 510(k)s)
- Espe Dental-Medizin GmbH & Co.Kg. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Espe-Premier Sales Co.?
FDA lists 10 510(k) clearances under the applicant name “Espe-Premier Sales Co.” (first 1981, latest 1981), across 7 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 Espe-Premier Sales Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Espe-Premier Sales Co. is 31 days.
Which FDA product codes appear under Espe-Premier Sales Co.?
The most frequent FDA product codes under this applicant name are KLE (Agent, Tooth Bonding, Resin, 3); EBF (Material, Tooth Shade, Resin, 2); EBC (Sealant, Pit And Fissure, And Conditioner, 1).
Next steps
- See all 10 Espe-Premier Sales Co. clearances with predicates and recalls
- Run predicate analysis for product code KLE, Espe-Premier Sales Co.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.