USI DENTAL SCALER, 25XXX SERIES— 510(k) K062791

Substantially Equivalent

Ultrasonic Services, Inc.

FDA 510(k) clearance K062791 for USI DENTAL SCALER, 25XXX SERIES, Substantially Equivalent on 2006-12-11. Applicant: Ultrasonic Services, Inc.. Device class: 2.

Clearance details

Applicant: Ultrasonic Services, Inc.
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 2006-09-18
Decision date: 2006-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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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.