NOVUS BONDING AGENT— 510(k) K900301

Substantially Equivalent

The Hygenic Corp.

FDA 510(k) clearance K900301 for NOVUS BONDING AGENT, Substantially Equivalent on 1990-05-15. Applicant: The Hygenic Corp..

Clearance details

Applicant: The Hygenic Corp.
Product code: Code EBI
Advisory panel: Dental
Date received: 1990-01-22
Decision date: 1990-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, 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.