Nobel Biocare AB - FDA 510(k) Cleared Devices

Nobel Biocare AB, is a medical device manufacturer based in Goteborg, Sweden. The company specializes in implant systems and related technologies for oral and maxillofacial applications.

Nobel Biocare AB has received 92 FDA 510(k) clearances from 92 total submissions since 2002. The company's regulatory portfolio is dominated by Dental devices, which account for approximately 86% of submissions. Recent clearances include implant systems, abutments, and digital imaging software, with the latest FDA 510(k) clearance in 2026, demonstrating continued regulatory activity.

The company's cleared devices span Dental implant systems, prosthetic components, and radiology software. Notable product lines include implant systems with titanium and zirconia materials, clinical abutments, and digital clinic imaging platforms.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database.

Regulatory submissions have been managed by Nobel Biocare USA, LLC, Nobel Biocare C/O Medicim NV and Nobel Biocare Services AG.