AMDENT MODEL 830 ULTRASONIC SCALER— 510(k) K880940

Substantially Equivalent

Pathway Products, Inc.

FDA 510(k) clearance K880940 for AMDENT MODEL 830 ULTRASONIC SCALER, Substantially Equivalent on 1988-07-15. Applicant: Pathway Products, Inc..

Clearance details

Applicant: Pathway Products, Inc.
Product code: Code ELC
Advisory panel: Dental
Date received: 1988-03-07
Decision date: 1988-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.