# K162043: NobelProcera HT ML FCZ Bridge

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Nov 22, 2016 after 120 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: 3 generations back to K910611 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153534: NobelProcera HT ML Full Contour Zirconia Crown, Nobel Biocare AB (2016) Summary page 4.

## Indications for use
NobelProcera® HT ML FCZ Bridge is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. NobelProcera® HT ML FCZ Bridge is indicated for use as a bridge that will be cemented on natural teeth or artificial abutments.

Source page: https://510kreport.com/device/K162043
Methodology: https://510kreport.com/methodology