VISIONER 21-A— 510(k) K901037

Substantially Equivalent

J. Morita USA, Inc.

FDA 510(k) clearance K901037 for VISIONER 21-A, Substantially Equivalent on 1990-08-14. Applicant: J. Morita USA, Inc..

Clearance details

Applicant: J. Morita USA, Inc.
Product code: Code EKS
Advisory panel: Dental
Date received: 1990-03-06
Decision date: 1990-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EKS

product code EKS

Malfunction: 1,949
Total: 1,949

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.