# K153534: NobelProcera HT ML Full Contour Zirconia Crown

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jun 6, 2016 after 180 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.
3 later devices descend from it; 3 cite it directly.
0 of 8 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 4.

## Most influential descendants
- K240586: Additive Manufacturing Zirconia Customized Restoration (2024), 0 descendants of its own
- K203072: Franz Zirconia Dental Crown (2022), 0 descendants of its own
- K162043: NobelProcera HT ML FCZ Bridge (2016), 0 descendants of its own

## Indications for use
NobelProcera HT ML FCZ Crown 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 Crown is indicated for use as single crown that will be cemented to a natural or artificial tooth abutment.

Source page: https://510kreport.com/device/K153534
Methodology: https://510kreport.com/methodology