# K041283: Procera Bridge Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: May 28, 2004 after 15 days
- Product code: ELL (Teeth, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.3920
- 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 K910611 (1991). 4 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032562: Proceara Copings and Pontic, Nobel Biocare AB (2004) Summary page 1.

## Most influential descendants
- K053050: Procera Bridge Alumina (2006), 1 descendant of its own
- K053125: Procera Bridge Zirconia (2006), 1 descendant of its own
- K130184: Zenolux (2013), 0 descendants of its own
- K091362: Ceramic Pedatric Preformed Crown (2009), 0 descendants of its own
- K071182: Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013 (2007), 0 descendants of its own

## Indications for use
Nobel Biocare's Procera® Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera® Bridge Zirconia may be two, three, or four units and are cemented to natural or artificial tooth abutments.

Source page: https://510kreport.com/device/K041283
Methodology: https://510kreport.com/methodology