CeraRoot TL Implant System (TL)— 510(k) K242072

Substantially Equivalent

Ceraroot SL

FDA 510(k) clearance K242072 for CeraRoot TL Implant System (TL), Substantially Equivalent on 2025-05-14. Applicant: Ceraroot SL.

Clearance details

Applicant: Ceraroot SL
Product code: Code DZE
Advisory panel: Dental
Date received: 2024-07-16
Decision date: 2025-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Les Franqueses Del Valles, ES

Download summary PDF View on FDA.gov ↗

Adverse 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, 2020-01-01 through 2026-04-23. 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.