K043497

Substantially Equivalent

AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV

Applicant: J. Morita USA, Inc.
Product code: EFB
Advisory panel: Dental
Date received: 2004-12-17
Decision date: 2005-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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.