# K160158: NobelProcera HT ML FCZ Implant Bridge and Framework

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jul 25, 2016 after 180 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: 9 generations back to K944964 (1995). 64 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091907: Nobelprocera Implant Bridge Zirconia, Nobel Biocare AB (2009) Summary page 4.
- K132746: Nobelprocera Angulated Screw Channel Abutment Conical Connection, Nobel Biocare USA, LLC (2014) Summary page 4.

## Most influential descendants
- K202452: NobelProcera Zirconia Implant Bridge (2020), 2 descendants of its own
- K253999: Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw (2026), 0 descendants of its own
- K240346: NobelProcera Zirconia Implant Bridge (2025), 0 descendants of its own

## Indications for use
The NobelProcera® HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

Source page: https://510kreport.com/device/K160158
Methodology: https://510kreport.com/methodology