# K161025: priti multidisc ZrO2 High Translucent

- Pathway: 510(k) (Traditional)
- Applicant: Pritidenta GmbH
- Decided: Feb 3, 2017 after 297 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: 3 generations back to K011394 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140070: Luxer Shaded Zirconia, Continental Dental Ceramics, Inc. (2014) Summary page 6.

## Indications for use
priti®multidisc ZrO2 High Translucent are pre-sintered zirconium oxide blanks for use in CNC (Computer Numerical Controls) milling machines to fabricate partial and single anterior and lateral crowns, bridges up to 3 units, inlays, onlays, and veneers for dental prostheses for restoration purposes only.

Source page: https://510kreport.com/device/K161025
Methodology: https://510kreport.com/methodology