# K071182: Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jul 11, 2007 after 72 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: 4 generations back to K910611 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053125: Procera Bridge Zirconia, Nobel Biocare AB (2006) Summary page 1.

## 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 cemented or bonded to either natural or artificial tooth abutments.

Source page: https://510kreport.com/device/K071182
Methodology: https://510kreport.com/methodology