3M Deutschland GmbH: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “3M Deutschland GmbH” (first 2012, latest 2022), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 64 days. Since 2017 the median was 10 days, against 121 days for all cleared 510(k)s in the same product codes. 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 | 79 |
| 2013 | 1 | 15 |
| 2014 | 2 | 170 |
| 2015 | 1 | 138 |
| 2016 | 3 | 162 |
| 2017 | 1 | 11 |
| 2018 | 0 | — |
| 2019 | 2 | 10 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 1 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name 3M Deutschland GmbH took a median 10 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELW | Material, Impression | 5 | 5 |
| EMA | Cement, Dental | 2 | 2 |
| PIP | Prophy Powder, Airbrush Accessory | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (12)
Most recent 3M Deutschland GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220257 | Permadyne | ELW | 2022-02-01 | 1 |
| K192992 | Suglue 3 | EMA | 2019-11-05 | 11 |
| K192961 | ADH19 | KLE | 2019-10-31 | 9 |
| K173318 | Rapid HB, Rapid LB, Rapid MB | ELW | 2017-10-31 | 11 |
| K161922 | XP202 | EIH | 2016-09-01 | 50 |
| K153174 | Ketac Universal Aplicap | EMA | 2016-04-13 | 162 |
| K151748 | Clean & More | PIP | 2016-03-11 | 256 |
| K151144 | SuPro 100 | EBG | 2015-09-14 | 138 |
| K140684 | CLINPRO PROPHY POWDER | PIP | 2014-10-24 | 220 |
| K133436 | FLASH AR; FLASH AR QUICK | ELW | 2014-03-07 | 119 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 3M Deutschland GmbH.
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 Deutschland GmbH?
FDA lists 12 510(k) clearances under the applicant name “3M Deutschland GmbH” (first 2012, latest 2022), across 6 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 Deutschland GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3M Deutschland GmbH is 64 days. Since 2017: 10 days, versus 121 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under 3M Deutschland GmbH?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 5); EMA (Cement, Dental, 2); PIP (Prophy Powder, Airbrush Accessory, 2).
Next steps
- See all 12 3M Deutschland GmbH clearances with predicates and recalls
- Run predicate analysis for product code ELW, 3M Deutschland GmbH'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.