# K260152: Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)

- Pathway: 510(k) (Traditional)
- Applicant: Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.
- Decided: Apr 23, 2026 after 93 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K042819 (2004). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222623: Digital Crown, Sprintray, Inc. (2022) Summary page 5.

## Indications for use
Smart Print Bio Vitality is a light-curable resin intended for the fabrication of definitive dental restorations. The material can be used to produce single crowns, veneers, inlays, onlays, and artificial teeth for dental prostheses. It is also suitable for the production of removable definitive full dentures, as well as individual and removable monolithic full and partial dentures in dental offices and laboratories. The product is indicated for anterior and posterior restorations, providing an alternative to conventional restorative materials in both clinical and laboratory settings.

Source page: https://510kreport.com/device/K260152
Methodology: https://510kreport.com/methodology