K953589

Substantially Equivalent

TOKUYAMA SOFT RELINING

Applicant: Tokuyama America, Inc.
Product code: EBI
Advisory panel: Dental
Date received: 1995-08-01
Decision date: 1996-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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.