Polibond— 510(k) K232691

Substantially Equivalent

Zirkonzahn Srl

FDA 510(k) clearance K232691 for Polibond, Substantially Equivalent on 2023-09-05. Applicant: Zirkonzahn Srl.

Clearance details

Applicant: Zirkonzahn Srl
Product code: Code EBI
Advisory panel: Dental
Date received: 2023-09-01
Decision date: 2023-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gais, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.