# K190139: Zircos-Com

- Pathway: 510(k) (Traditional)
- Applicant: Bioden Co., Ltd.
- Decided: Apr 24, 2020 after 451 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 K051867 (2005). 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)
- K102351: Grandio SO, Voco GmbH (2010) Summary page 4.

## Indications for use
- Direct fillings of Class Ⅰ to Ⅴ restorations - Shape and shade corrections

Source page: https://510kreport.com/device/K190139
Methodology: https://510kreport.com/methodology