Espe Dental AG: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Espe Dental AG” (first 1998, latest 2001), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| ELW | Material, Impression | 10 | 10 |
| EBF | Material, Tooth Shade, Resin | 6 | 6 |
| KLE | Agent, Tooth Bonding, Resin | 4 | 4 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 2 | 2 |
| EMA | Cement, Dental | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EFD | Amalgamator, Dental, Ac-Powered | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
Review panels
- Dental (29)
Most recent Espe Dental AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011394 | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM | EIH | 2001-06-29 | 53 |
| K011154 | ELIPAR FREELIGHT | EBZ | 2001-05-16 | 30 |
| K002793 | KETAC CEM U | EMA | 2000-09-26 | 19 |
| K002364 | PROTEMP H | EBG | 2000-08-10 | 7 |
| K001494 | MODIFICATION TO PROMPT L-POP | KLE | 2000-07-07 | 56 |
| K000595 | DIMENSION PENTA L | ELW | 2000-04-05 | 43 |
| K000591 | DIMENSION PENTA H, DIMENSION PENTA H QUICK | ELW | 2000-03-30 | 37 |
| K000588 | DIMENSION GARANT L, DIMENSION GARANT L QUICK | ELW | 2000-03-30 | 37 |
| K994193 | IMPREGUM PENTA DUOSOFT | ELW | 2000-01-28 | 46 |
| K994192 | IMPREGUM PENTA M MONOSOFT | ELW | 2000-01-28 | 46 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Espe Dental AG.
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 GmbH & Co. Kg. (17 510(k)s)
- Espe-Premier Sales Co. (10 510(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 Dental AG?
FDA lists 29 510(k) clearances under the applicant name “Espe Dental AG” (first 1998, latest 2001), across 9 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 Dental AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Espe Dental AG is 43 days.
Which FDA product codes appear under Espe Dental AG?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 10); EBF (Material, Tooth Shade, Resin, 6); KLE (Agent, Tooth Bonding, Resin, 4).
Next steps
- See all 29 Espe Dental AG clearances with predicates and recalls
- Run predicate analysis for product code ELW, Espe Dental AG'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.