FDA applicant
3M Company, Unitek Orthodontic Products
FDA records 3 decisions for 3M Company, Unitek Orthodontic Products (Saint Paul, MN) from 2021 to 2023: 3 510(k) clearances. All are in product code NXC (Aligner, Sequential). Since 2016 its 510(k)s took a median of 2 days from receipt to decision, against 152 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided 3M Company, Unitek Orthodontic Products’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like 3M Company, Unitek Orthodontic Products’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report