# K163346: MAZIC Duro

- Pathway: 510(k) (Traditional)
- Applicant: Vericom Co., Ltd.
- Decided: Mar 17, 2017 after 108 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: 4 generations back to K042819 (2004). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133824: Cerasmart, GC America, Inc. (2014) Summary page 4.

## Indications for use
Fabrication of inlays, onlays, veneers and crowns

Source page: https://510kreport.com/device/K163346
Methodology: https://510kreport.com/methodology