# K230098: Trusana™

- Pathway: 510(k) (Traditional)
- Applicant: Myerson, LLC
- Decided: Apr 13, 2023 after 90 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K011560 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191497: NextDent Denture 3D+, Vertex-Dental B.V. (2019) Summary page 4.

## Indications for use
Trusana™ resin is intended to 3D print denture base for use in making removable full and partial dentures or overdentures. Trusana™ is intended exclusively for professional dental work. Fabrication of denture bases with Trusana™ requires a computer-aided and manufacturing (CAD/CAM) system using the Asiga MAX UV or Asiga PRO 4K 3D printer in conjunction with the Asiga Flash curing chamber.

Source page: https://510kreport.com/device/K230098
Methodology: https://510kreport.com/methodology