# K010630: Y-TZP Powder and Procera Allzirkon

- Pathway: 510(k) (Traditional)
- Applicant: Procera Sandvik, Inc.
- Decided: Apr 17, 2001 after 46 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
No predicates in its family tree.
30 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032562: Proceara Copings and Pontic (2004), 29 descendants of its own
- K060530: SD Ceramic Coping for Quick Abutment, Locking. Model 45301.  RD Ceramic Coping for Quick Abutment, Locking, Model 45302. (2006), 15 descendants of its own
- K072241: Primaconnex Cad/Cam Abutment System (2007), 7 descendants of its own
- K062876: Primaconnex Ceramic Abutments (2006), 6 descendants of its own
- K041283: Procera Bridge Zirconia (2004), 5 descendants of its own

Source page: https://510kreport.com/device/K010630
Methodology: https://510kreport.com/methodology