# K053091: Procera Implant Bridge Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jan 27, 2006 after 85 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: 7 generations back to K944964 (1995). 60 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043042: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052, Nobel Biocare AB (2004) Summary page 1.
- K041236: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052, Nobel Biocare AB (2004) Summary page 1.

## Most influential descendants
- K091907: Nobelprocera Implant Bridge Zirconia (2009), 5 descendants of its own
- K160158: NobelProcera HT ML FCZ Implant Bridge and Framework (2016), 3 descendants of its own
- 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 Procera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. In addition to Nobel Biocare implant systems, the Procera Implant Bridge Zirconia can be used on the following implant systems: - Straumann Dental Implant System Regular Neck 4.8 - Straumann Dental Implant System Wide Neck 6.5 - 3i 3.75 - Lifecore Biomedical Restore 3.75 - Zimmer Dental Taper-Lock 4.0 - Sterngold Implamed 3.75

Source page: https://510kreport.com/device/K053091
Methodology: https://510kreport.com/methodology
