PRE-DENT— 510(k) K791200

Substantially Equivalent

Fichte, Graves, and Hunt

FDA 510(k) clearance K791200 for PRE-DENT, Substantially Equivalent on 1979-08-10. Applicant: Fichte, Graves, and Hunt.

Clearance details

Applicant: Fichte, Graves, and Hunt
Product code: Code GIM
Advisory panel: Clinical Chemistry
Date received: 1979-06-28
Decision date: 1979-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GIM

product code GIM

Malfunction: 1,325
Total: 1,325

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.