K974670

Substantially Equivalent

ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE

Applicant: Athena Technology, Inc.
Product code: EFB
Advisory panel: Dental
Date received: 1997-12-15
Decision date: 1998-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Dimas, CA, US

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Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.