K-SPRAY, MODEL 085-2715— 510(k) K062418

Substantially Equivalent

Scican

FDA 510(k) clearance K062418 for K-SPRAY, MODEL 085-2715, Substantially Equivalent on 2006-10-19. Applicant: Scican.

Clearance details

Applicant: Scican
Product code: Code EFB
Advisory panel: Dental
Date received: 2006-08-18
Decision date: 2006-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.