K844572

Substantially Equivalent

PRE-KLENE ENAMEL CLEANER

Applicant: Medical Products Laboratories, Inc.
Product code: EFT
Advisory panel: Dental
Date received: 1984-11-23
Decision date: 1985-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Adverse events under product code EFT

product code EFT

Death: 8
Injury: 267
Total: 275

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.