# K151875: Pavati Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Ccri, Inc.
- Decided: Oct 29, 2015 after 112 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: 2 generations back to K060104 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062509: Incoris ZI, Sirona Dental Systems GmbH (2006) Summary page 4.
- K123545: Incoris Tzi, Sirona Dental Systems GmbH (2013) Summary page 4.

## Indications for use
Pavati™ Zirconia blanks are indicated for use in prosthetic dentistry to create poreelain (ceramic) prostheses (crowns and bridges) in the anterior/ posterior applications. Pavati™ Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use. Pavati™ Zirconia blanks are for "Rx only” and not for use by the general public or sold as “Over-the-Counter”

Source page: https://510kreport.com/device/K151875
Methodology: https://510kreport.com/methodology