LYSTA HYGIENIST III SCALER— 510(k) K904296

Substantially Equivalent

Prodent Intl., Inc.

FDA 510(k) clearance K904296 for LYSTA HYGIENIST III SCALER, Substantially Equivalent on 1990-12-05. Applicant: Prodent Intl., Inc..

Clearance details

Applicant: Prodent Intl., Inc.
Product code: Code ELC
Advisory panel: Dental
Date received: 1990-09-19
Decision date: 1990-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.