FDA applicant
3M Unitek Orthodontic Products
FDA records 1 decision for 3M Unitek Orthodontic Products (Monrovia, CA) in 2023: 1 510(k) clearance. All are in product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin). Its devices cite 1 predicate, 0 of them its own earlier devices. No 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 Unitek Orthodontic Products’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like 3M 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