HYGIENTIST; CYCLOSON I & II; RETROFIT— 510(k) K812909

Substantially Equivalent

Fibra Sonics, Inc.

FDA 510(k) clearance K812909 for HYGIENTIST; CYCLOSON I & II; RETROFIT, Substantially Equivalent on 1981-12-14. Applicant: Fibra Sonics, Inc..

Clearance details

Applicant: Fibra Sonics, Inc.
Product code: Code ELC
Advisory panel: Dental
Date received: 1981-10-19
Decision date: 1981-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.