PRE-KLENE ENAMEL CLEANER— 510(k) K844572

Substantially Equivalent

Medical Products Laboratories, Inc.

FDA 510(k) clearance K844572 for PRE-KLENE ENAMEL CLEANER, Substantially Equivalent on 1985-01-18. Applicant: Medical Products Laboratories, Inc..

Clearance details

Applicant: Medical Products Laboratories, Inc.
Product code: 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

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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.