3M Espe Dental Products: FDA clearances and approvals
3M Espe Dental Products has 12 FDA 510(k) clearances (first 2006, latest 2023), across 5 product codes in 1 review panel. Median 510(k) review time: 23 days. Since 2017 its median was 11 days, against 116 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named 3M Espe Dental Products.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 34 |
| 2013 | 0 | — |
| 2014 | 1 | 13 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 23 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 4 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 3M Espe Dental Products's cleared 510(k)s took a median 11 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 4 | 4 |
| EMA | Cement, Dental | 4 | 4 |
| LBH | Varnish, Cavity | 2 | 2 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (12)
Most recent 3M Espe Dental Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231338 | 3M Clinpro Clear 2.1% Sodium Fluoride Treatment | LBH | 2023-05-10 | 2 |
| K230270 | 3M VitCal Liner/Base | EJK | 2023-02-06 | 6 |
| K191122 | 3M RelyX Pediatric Resin Modified Glass Ionomer Cement | EMA | 2019-05-29 | 30 |
| K183476 | 3M Filtek Universal Restorative | EBF | 2019-01-02 | 16 |
| K141081 | FILTEK BULK FILL POSTERIOR RESTROATIVE | EBF | 2014-05-08 | 13 |
| K120453 | FILTEK BULK FILL FLOWABLE RESTORATIVE | EBF | 2012-03-19 | 34 |
| K111185 | RELYX LUTING PLUS AUTOMIX | EMA | 2011-05-05 | 8 |
| K110131 | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE | EBF | 2011-01-21 | 3 |
| K092141 | VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH | LBH | 2010-03-10 | 238 |
| K073395 | GILB-2, GLASS IONOMER PROTECTIVE COATING | EMA | 2008-01-17 | 45 |
2 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-02-12.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does 3M Espe Dental Products have?
3M Espe Dental Products has 12 FDA 510(k) clearances (first 2006, latest 2023), across 5 product codes in 1 review panel.
How long does FDA take to clear 3M Espe Dental Products's 510(k)s?
The median time from FDA receipt to decision across 3M Espe Dental Products's cleared 510(k)s is 23 days. Since 2017: 11 days, versus 116 days for all cleared 510(k)s in the same product codes.
What devices does 3M Espe Dental Products make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 4); EMA (Cement, Dental, 4); LBH (Varnish, Cavity, 2).
Has 3M Espe Dental Products had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches 3M Espe Dental Products; the most recent began 2007-02-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 12 3M Espe Dental Products clearances with predicates and recalls
- Run predicate analysis for product code EBF, 3M Espe Dental Products's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.