# K191304: EthanZir Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Besorah Dental Solutions NZ Limited
- Decided: Nov 4, 2019 after 174 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K060104 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060104: Prismatik Clinical Zirconia, Glidewell Laboratories (2006) Summary page 4.

## Indications for use
EthanZir™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). EthanZir™ Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. Substructure ceramic for prostheses involving four or more units can be created.

Source page: https://510kreport.com/device/K191304
Methodology: https://510kreport.com/methodology