Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL— 510(k) K230104

Substantially Equivalent

Anthogyr

FDA 510(k) clearance K230104 for Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL, Substantially Equivalent on 2023-10-16. Applicant: Anthogyr.

Clearance details

Applicant: Anthogyr
Product code: Code DZE
Advisory panel: Dental
Date received: 2023-01-13
Decision date: 2023-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sallanches, FR

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.