# K191306: Llis, Vittra APS

- Pathway: 510(k) (Traditional)
- Applicant: Dentscare Ltda
- Decided: Dec 16, 2019 after 216 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: 3 generations back to K083610 (2008). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183476: 3M Filtek Universal Restorative, 3M Espe Dental Products (2019) Summary page 5.

## Most influential descendants
- K210231: Vittra APS Unique (2021), 0 descendants of its own

## Indications for use
The Llis and VITTRA APS composite is suitable for use in: - Direct restorations in anterior and posterior teeth (I, II, III, IV, V e VI); - Core build-ups; - Teeth splinting; - Indirect restorations such as inlays, onlays and veneers. - Direct veneers with composites; - Restoration of deciduous teeth - Diastema closing or reduction; - Modification of teeth's shape (e.g.: conoid teeth); - Cementation of tooth fragments; - Porcelain/composite repairs;

Source page: https://510kreport.com/device/K191306
Methodology: https://510kreport.com/methodology