3M Unitek: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “3M Unitek” (first 1995, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 71 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 | 94 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 30 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 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 Unitek took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 6 | 6 |
| NJM | Bracket, Ceramic, Orthodontic | 2 | 2 |
| NXC | Aligner, Sequential | 1 | 1 |
Review panels
- Dental (9)
Most recent 3M Unitek 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163689 | 3M Clear Tray Aligner | NXC | 2017-01-27 | 30 |
| K113197 | APC FLASH-FREE ADHESIVE | DYH | 2012-02-02 | 94 |
| K102803 | CLARITY ADVANCED CERAMIC BRACKETS | NJM | 2011-02-17 | 142 |
| K100536 | TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE | DYH | 2010-07-27 | 152 |
| K073697 | TRANSBOND SUPREME ADHESIVE | DYH | 2008-02-15 | 46 |
| K062305 | CLARITY MODIFIED CERAMIC BRACKETS | NJM | 2006-10-18 | 71 |
| K020394 | APC PLUS ADHESIVE | DYH | 2002-04-12 | 65 |
| K014142 | UNITE BONDING ADHESIVE | DYH | 2002-02-28 | 73 |
| K950514 | TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT | DYH | 1995-03-07 | 29 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-11-26.
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 Unitek?
FDA lists 9 510(k) clearances under the applicant name “3M Unitek” (first 1995, latest 2017), across 3 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 Unitek?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3M Unitek is 71 days.
Which FDA product codes appear under 3M Unitek?
The most frequent FDA product codes under this applicant name are DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 6); NJM (Bracket, Ceramic, Orthodontic, 2); NXC (Aligner, Sequential, 1).
Next steps
- See all 9 3M Unitek clearances with predicates and recalls
- Run predicate analysis for product code DYH, 3M Unitek'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.