SONICWAVE SONIC PLAQUE REMOVER— 510(k) K012914

Substantially Equivalent

Homedics, Inc.

FDA 510(k) clearance K012914 for SONICWAVE SONIC PLAQUE REMOVER, Substantially Equivalent on 2001-10-01. Applicant: Homedics, Inc..

Clearance details

Applicant: Homedics, Inc.
Product code: Code JEQ
Advisory panel: Dental
Date received: 2001-08-30
Decision date: 2001-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Commerce Township, MI, 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.