Nobel Biocare AB · Class II · Cleared Jan 3, 2025
| K-number | K240346 |
| Device name | NobelProcera Zirconia Implant Bridge |
| Applicant | Nobel Biocare AB |
| Product code | NHA |
| Device class | Class II |
| Decision date | Jan 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3630 |
The NobelProcera Zirconia Implant Bridge is a patient-specific, screw-retained dental bridge made of yttria-stabilized zirconia that attaches to dental implants or multi-unit abutments. It is designed using CAD/CAM software and manufactured industrially, then sent to a laboratory for finishing. The device is indicated to restore chewing function in partially or fully edentulous patients, with bridge spans of 2 to 14 units supported by 2 to 10 dental implants.
The subject device is substantially identical to the predicate in material (Y-TZP zirconia), design workflow (CAD), manufacturing (industrialized), attachment method (screw-retained), and compatibility with multiple implant platforms (Internal Conical Connection, External Hex, Internal Tri-Channel, and Multi-unit Abutments). The primary difference is an increase in maximum extension length from 10 mm to 16 mm, which was validated by fatigue testing using worst-case scenarios with identical testing protocols to the reference device.
Testing was conducted in accordance with FDA Guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.' Materials conform to ISO 13356 (yttria-stabilized tetragonal zirconia) and ASTM F136 / ISO 5832-3 (titanium aluminum vanadium alloy for prosthetic screws). Fatigue testing of finished assembled implant/abutment systems examined worst-case scenarios using identical protocols to reference device K161416.
The subject device shares identical intended use, material composition, design methodology, manufacturing workflow, and technological specifications with the predicate device K202452. The only difference—maximum extension length increased from 10 mm to 16 mm—does not raise new safety or effectiveness questions because fatigue testing of worst-case scenarios using identical protocols to reference device K161416 demonstrated comparable performance. Therefore, the device is substantially equivalent despite this minor specification change.
View the full FDA submission: accessdata.fda.gov