K252197 is an FDA 510(k) clearance for the Nobel Biocare S Series Implants. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on February 18, 2026, 219 days after receiving the submission on July 14, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K252197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2025 |
| Decision Date | February 18, 2026 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |