TKD SCALERS— 510(k) K000846

Substantially Equivalent

Orasystems

FDA 510(k) clearance K000846 for TKD SCALERS, Substantially Equivalent on 2000-12-04. Applicant: Orasystems.

Clearance details

Applicant: Orasystems
Product code: Code ELC
Advisory panel: Dental
Date received: 2000-03-15
Decision date: 2000-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NJ, 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.