OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142— 510(k) K926246

Substantially Equivalent

Omron Healthcare, Inc.

FDA 510(k) clearance K926246 for OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142, Substantially Equivalent on 1993-04-14. Applicant: Omron Healthcare, Inc..

Clearance details

Applicant: Omron Healthcare, Inc.
Product code: Code JEQ
Advisory panel: Dental
Date received: 1992-12-14
Decision date: 1993-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

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Adverse events under product code JEQ

product code JEQ

Injury: 188
Malfunction: 2,818
Total: 3,006

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.