# K053068: Procera Bridge Laminate, Model 40-4002

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Feb 22, 2006 after 113 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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.
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)
- K032562: Proceara Copings and Pontic, Nobel Biocare AB (2004) Summary page 1.

## Indications for use
Nobel Biocare's Procera Bridge Laminate is indicated for use as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region. The bridge is bonded onto natural teeth.

Source page: https://510kreport.com/device/K053068
Methodology: https://510kreport.com/methodology