# K254245: Zafira®

- Pathway: 510(k) (Traditional)
- Applicant: New Stetic, SA
- Decided: Mar 3, 2026 after 64 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: 2 generations back to K111958 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183380: Tetric PowerFill, Ivoclar Vivadent, AG (2019) Summary page 5.

## Indications for use
ZAFIRA® is indicated as a direct and indirect restorative material. ZAFIRA® Light Curing Composite is intended for: - Posterior restorations (Class I and II) - Anterior restorations (Class 11l and IV) - Cervical restorations (Class V) - Restoration of deciduous teeth - Direct veneers - Indirect restorations (inlays, onlays, and veneers) ZAFIRA® Light Curing Gum Composite is intended for reproduction of gingiva in prosthetic restorations including: - Implant restorations - Crowns and bridges - Full or partial prostheses

Source page: https://510kreport.com/device/K254245
Methodology: https://510kreport.com/methodology