Espe GmbH (Us): FDA filings under this applicant name
FDA lists 59 510(k) clearances under the applicant name “Espe GmbH (Us)” (first 1977, latest 1993), across 17 product codes in 1 review panel. Median 510(k) review time under this name: 77 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 | 13 | 13 |
| EMA | Cement, Dental | 10 | 10 |
| KLE | Agent, Tooth Bonding, Resin | 8 | 8 |
| ELW | Material, Impression | 7 | 7 |
| EBG | Crown And Bridge, Temporary, Resin | 3 | 3 |
| EBH | Material, Impression Tray, Resin | 3 | 3 |
| EJK | Liner, Cavity, Calcium Hydroxide | 3 | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 2 |
| EID | Syringe, Restorative And Impression Material | 2 | 2 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
Plus 7 more product codes.
Review panels
- Dental (59)
Most recent Espe GmbH (Us) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925027 | PHOTAC-FIL APLICAP | EMA | 1993-06-18 | 259 |
| K915005 | PHOTAC-BOND APLICAP, MODIFICATION | EMA | 1992-01-14 | 68 |
| K913966 | SONO(R) -CEM | EBF | 1992-01-14 | 131 |
| K913857 | ROCATEC(R) -PLUS | EJH | 1991-12-16 | 111 |
| K913965 | ESPE(R) -SIL | KLE | 1991-12-04 | 90 |
| K905604 | VISIO-GEM ART-SYSTEM | EBF | 1991-03-29 | 108 |
| K904096 | PHOTAC-BOND | EJK | 1990-11-19 | 74 |
| K904097 | PHOTAC-BOND APLICAP | EJK | 1990-11-09 | 64 |
| K904289 | PERTAC UNIVERSAL BOND | KLE | 1990-11-01 | 45 |
| K900510 | PERTAC-HYBRID | EBF | 1990-08-09 | 188 |
49 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Espe GmbH (Us).
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 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 GmbH (Us)?
FDA lists 59 510(k) clearances under the applicant name “Espe GmbH (Us)” (first 1977, latest 1993), across 17 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 GmbH (Us)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Espe GmbH (Us) is 77 days.
Which FDA product codes appear under Espe GmbH (Us)?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 13); EMA (Cement, Dental, 10); KLE (Agent, Tooth Bonding, Resin, 8).
Next steps
- See all 59 Espe GmbH (Us) clearances with predicates and recalls
- Run predicate analysis for product code EBF, Espe GmbH (Us)'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.