BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER— 510(k) K130137

Substantially Equivalent

Coltene/Whaledent

FDA 510(k) clearance K130137 for BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER, Substantially Equivalent on 2013-08-23. Applicant: Coltene/Whaledent.

Clearance details

Applicant: Coltene/Whaledent
Product code: Code ELC
Advisory panel: Dental
Date received: 2013-01-18
Decision date: 2013-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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.