3M Espe AG Dental Products: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “3M Espe AG Dental Products” (first 2002, latest 2010), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 64 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 | 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 | 7 | 7 |
| EMA | Cement, Dental | 4 | 4 |
| EIH | Powder, Porcelain | 3 | 3 |
| ELW | Material, Impression | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| KOJ | Airbrush | 1 | 1 |
| MVL | Cord, Retraction | 1 | 1 |
Review panels
- Dental (24)
Most recent 3M Espe AG Dental Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100908 | UNICEM HM | EMA | 2010-06-22 | 82 |
| K100756 | MALTA | EMA | 2010-06-02 | 77 |
| K094007 | UNICEM | EMA | 2010-04-08 | 101 |
| K093721 | COSP2 | MVL | 2010-02-19 | 79 |
| K091826 | ELEGANT | EIH | 2009-09-25 | 98 |
| K090718 | BELLUS SHADING KIT | EIH | 2009-09-21 | 187 |
| K080514 | PECD-01 AND PECD QUICK-01 | ELW | 2008-03-26 | 30 |
| K072055 | LAVA FRAME, LAVA FRAME SHADE | NHA | 2008-02-26 | 215 |
| K073296 | TEMPXN28 | EBG | 2008-01-09 | 47 |
| K071131 | UNO | KLE | 2007-07-25 | 93 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 3M Espe AG Dental Products.
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 Dental Products?
FDA lists 24 510(k) clearances under the applicant name “3M Espe AG Dental Products” (first 2002, latest 2010), 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 3M Espe AG Dental Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3M Espe AG Dental Products is 64 days.
Which FDA product codes appear under 3M Espe AG Dental Products?
The most frequent FDA product codes under this applicant name are KLE (Agent, Tooth Bonding, Resin, 7); EMA (Cement, Dental, 4); EIH (Powder, Porcelain, 3).
Next steps
- See all 24 3M Espe AG Dental Products clearances with predicates and recalls
- Run predicate analysis for product code KLE, 3M Espe AG Dental Products'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.