Bonafix 2 Plus— 510(k) K213677

Substantially Equivalent

Zentek Medical, LLC

FDA 510(k) clearance K213677 for Bonafix 2 Plus, Substantially Equivalent on 2022-12-20. Applicant: Zentek Medical, LLC.

Clearance details

Applicant: Zentek Medical, LLC
Product code: Code DZE
Advisory panel: Dental
Date received: 2021-11-22
Decision date: 2022-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manalapan, NJ, US

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.