ULTRASONIC SCALER COVER— 510(k) K884221

Substantially Equivalent

Steri-Shield Products, Inc.

FDA 510(k) clearance K884221 for ULTRASONIC SCALER COVER, Substantially Equivalent on 1989-03-17. Applicant: Steri-Shield Products, Inc..

Clearance details

Applicant: Steri-Shield Products, Inc.
Product code: Code ELC
Advisory panel: Dental
Date received: 1988-10-06
Decision date: 1989-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, 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.