# K243356: Asiga DentaBASE

- Pathway: 510(k) (Abbreviated)
- Applicant: Asiga Pty, Ltd.
- Decided: Apr 11, 2025 after 164 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 5.

## Indications for use
Asiga DentaBASE is intended exclusively for professional dental work. Asiga DentaBASE is a 3D print resin intended for the manufacturing of 3D printed denture bases. The denture bases produced are suitable for dental indications including removable dentures.

Source page: https://510kreport.com/device/K243356
Methodology: https://510kreport.com/methodology