ROYALE II— 510(k) K831095

Substantially Equivalent

Factor, Ii, Inc.

FDA 510(k) clearance K831095 for ROYALE II, Substantially Equivalent on 1983-08-31. Applicant: Factor, Ii, Inc..

Clearance details

Applicant: Factor, Ii, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 1983-04-04
Decision date: 1983-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.