TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS— 510(k) K034024

Substantially Equivalent

Bisco, Inc.

FDA 510(k) clearance K034024 for TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS, Substantially Equivalent on 2004-03-19. Applicant: Bisco, Inc..

Clearance details

Applicant: Bisco, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 2003-12-29
Decision date: 2004-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

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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.