TONY RISO 25/30 MULTIFUNCTION SCALER— 510(k) K964320

Substantially Equivalent

Tony Riso Co., Inc.

FDA 510(k) clearance K964320 for TONY RISO 25/30 MULTIFUNCTION SCALER, Substantially Equivalent on 1997-01-23. Applicant: Tony Riso Co., Inc..

Clearance details

Applicant: Tony Riso Co., Inc.
Product code: Code ELC
Advisory panel: Dental
Date received: 1996-10-29
Decision date: 1997-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, 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.