Nobel Biocare S Series Implants— 510(k) K252197
Substantially EquivalentNobel Biocare AB
FDA 510(k) clearance K252197 for Nobel Biocare S Series Implants, Substantially Equivalent on 2026-02-18. Applicant: Nobel Biocare AB. Device class: 2.
Summary
Nobel Biocare's Nobel Biocare S Series Implants are filed under product code DZE (Implant, Endosseous, Root-Form). The record gives no models or sizes.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Nobel Biocare filed from Goteborg, Sweden. The substantially equivalent decision came 219 calendar days after receipt (July 14, 2025 to February 18, 2026).
Clearance details
- Applicant
- Nobel Biocare AB
- Product code
- Product code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goteborg, SE
Recent devices under product code DZE
view allMore clearances from Nobel Biocare AB
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.