SCALEX 800— 510(k) K954820

Substantially Equivalent

Dentamerica

FDA 510(k) clearance K954820 for SCALEX 800, Substantially Equivalent on 1996-01-18. Applicant: Dentamerica.

Clearance details

Applicant: Dentamerica
Product code: Code ELC
Advisory panel: Dental
Date received: 1995-10-20
Decision date: 1996-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Industry, CA, 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.