Nobel Biocare
FDA Regulatory Profile
Nobel Biocare appears in FDA public data with 2 recalls, 94 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1101-2025, Class II) was initiated on January 10, 2025. Its most recent 510(k) clearance was granted on February 18, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 94
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1101-2025 | Class II | . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Bioca | January 10, 2025 |
| Z-1565-2022 | Class II | Nobel Biocare N1 TiUltra TCC NP 3.5x13mm | July 25, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252197 | Nobel Biocare S Series Implants | February 18, 2026 |
| K243834 | NobelZygoma TiUltra Implant system | August 25, 2025 |
| K240346 | NobelProcera Zirconia Implant Bridge | January 3, 2025 |
| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | January 24, 2024 |
| K231898 | DTX Studio Clinic (4.0) | December 8, 2023 |
| K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | April 28, 2023 |
| K221921 | DTX Studio Clinic 3.0 | March 28, 2023 |
| K213562 | DTX Studio Clinic 3.0 | March 25, 2022 |
| K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional | September 24, 2021 |
| K202452 | NobelProcera Zirconia Implant Bridge | December 3, 2020 |
| K203156 | DTX Studio Clinic | November 20, 2020 |
| K202344 | TiUltra Implants and Xeal Abutments | November 16, 2020 |
| K200810 | IPS CaseDesigner | October 8, 2020 |
| K200040 | Universal Base Conical Connection (CC) | March 30, 2020 |
| K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic P | August 29, 2019 |
| K181932 | DTX Studio design | March 1, 2019 |
| K173418 | NobelParallel Conical Connection | February 21, 2019 |
| K181869 | On1 Universal Abutment | December 12, 2018 |
| K183069 | NobelZygoma 0° | December 4, 2018 |
| K180899 | Universal Base Abutment | October 31, 2018 |