3M Espe AG: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “3M Espe AG” (first 2011, latest 2014), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 94 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Solventum (formerly 3M Health Care), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 10 |
| 2013 | 0 | — |
| 2014 | 2 | 104 |
| 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | 2 | 2 |
| ELW | Material, Impression | 2 | 2 |
| EMA | Cement, Dental | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (6)
Most recent 3M Espe AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140602 | FLASH PENTA MB QUICK, FLASH MB QUICK | ELW | 2014-06-05 | 87 |
| K133400 | FLASH BITE | ELW | 2014-03-06 | 120 |
| K120011 | HEISENBERG EFFECT SHADES | EIH | 2012-01-13 | 10 |
| K110508 | SUGLUE-10 | EMA | 2011-06-03 | 101 |
| K110302 | ADHESIVE EXL-759 | KLE | 2011-05-19 | 106 |
| K111257 | HEISENBERG DYEING LIQUIDS | EIH | 2011-05-13 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named 3M Espe 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under 3M Espe AG?
FDA lists 6 510(k) clearances under the applicant name “3M Espe AG” (first 2011, latest 2014), across 4 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 3M Espe AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3M Espe AG is 94 days.
Which FDA product codes appear under 3M Espe AG?
The most frequent FDA product codes under this applicant name are EIH (Powder, Porcelain, 2); ELW (Material, Impression, 2); EMA (Cement, Dental, 1).
Next steps
- See all 6 3M Espe AG clearances with predicates and recalls
- Run predicate analysis for product code EIH, 3M Espe 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, 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.